(263 days)
Not Found
No
The description details a manual resuscitator with mechanical components (mask, bulb, valve) and performance metrics based on physical characteristics and standards. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for pulmonary resuscitation, which involves inflating the lungs to keep a person oxygenated and alive, directly addressing a health condition.
No
The device is described as a resuscitator intended for pulmonary resuscitation, which is a therapeutic intervention to inflate the lungs and maintain oxygenation. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, hand-squeezed plastic bulb with a mask and valves, which are hardware components. The performance studies also focus on physical characteristics and functionality of this hardware.
Based on the provided information, the Revivator resuscitator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "pulmonary resuscitation," which involves directly assisting a person's breathing. This is a therapeutic intervention performed on the body.
- Device Description: The description details a mechanical device that provides positive pressure to inflate the lungs. This is a physical action on the patient.
- Anatomical Site: The device acts on the "Lungs, airways," which are internal anatomical structures.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical and functional characteristics of the device itself (tidal volume, pressure, resistance, oxygen concentration, etc.) and its ability to deliver air/oxygen to the patient. They do not involve analyzing samples taken from the body (like blood, urine, tissue, etc.) to diagnose a condition.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Revivator resuscitator does not perform this function. It is a life-support device used to assist breathing.
N/A
Intended Use / Indications for Use
The Revivator resuscitator is intended for pulmonary resuscitation.
The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs) The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs)
The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
Product codes (comma separated list FDA assigned to the subject device)
BTM
Device Description
A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep him oxygenated and alive. The manual resuscitators basically consist of a mask and a large hand-squeezed plastic bulb using ambient air, or supplemental oxygen.
The air and oxygen flows into the resuscitator bag. And compressing the bag, the patient is ventilated.
In order not to apply a high pressure to the patient's airways, the resuscitators include a pressure-limiting valve.
- Child/infant resuscitators: the pressure-limiting valve is set to open at 45 cm H2O. If higher pressures are required, press to block (no lock)
- Adult resuscitators: the pressure-limiting valve is set to open at 60 cm H2O. if higher pressures are required, press and turn to lock
Components (Fig. 8):
- Reservoir bag
- Reservoir valve
- Beg inlet valve
- Resuscitator Bag
- Patient valve
- Pressure-limiting valve
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
Indicated Patient Age Range
Adult (more than 30 kg / 66 lbs), Child (between 7 and 30 kg / 15-66 lbs), Infant (up to 7 kg / 15 lbs)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K993278, K924215, K924216, K042682, K042843, K911622, K970756
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for HERSILL, S.L., a company that specializes in medical devices. The logo includes the company name in bold letters, followed by the words "Equipos Medicos - Medical Devices". Below this is the company's address, which is C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The image also includes the company's telephone and fax numbers, which are +34 91 616 41 11 and +34 91 616 48 9, respectively, as well as the company's website address, which is www.hersill.com.
Image /page/0/Picture/1 description: The image contains three logos. The first logo has the letters CSQ on top of the letters MED, with the text EN ISO 13485:2003 below. The second logo has the letters CSQ with the text EN ISO 9001:2000 below. The third logo is a circle with the text CERTIFIED on top and MANAGEMENT SYSTEM on the bottom, with the letters IQNet in the center.
K094003
SEP 17 2010
"510(k) SUMMARY"
(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;
- SUBMITTER'S NAME: HERSILL, S.L. .
- ADRESS: Puerto de Navacerrada, 3, 28935 Móstoles, Madrid, SPAIN .
- TELEPHONE NUMBER: +34 91 616 41 11 .
- CONTACT PERSON: Miguel Óscar Martínez Jordán .
- . DATE (mm/dd/yyyy): 12/11/2009
(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;
- Trade Name: REVIVATOR ●
- . Models:
- REVIVATOR PLUS (adult, child, enfant) o
- O REVIVATOR RES-Q (adult, child)
- REVIVATOR KITS (PLUS, RES-Q) o
- Classification name: .
- Device: Ventilator, emergency, Manual (Resuscitator) o
- Product Code: BTM o
- Regulation Number: 868.5915 o
- Regulation description: Manual emergency ventilator o
(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 510(k) premarket notification process;
Submiter: Ambu, Inc.
- Ambu neonate silicone resuscitator (K993278) .
1
Image /page/1/Picture/0 description: The image shows the logo for HERSILL, S.L., a company that specializes in medical devices. The logo includes a stylized graphic to the left of the company name. Below the name is the text "Equipos Medicos - Medical Devices", followed by the address "C/ Puerto de Navacerrada, 3 28935 MOSTOLES - (Madrid) - Spain". The contact information includes the telephone number "+34 91 616 41 11", fax number "+34 91 616 48 92", and website "www.hersill.com".
Image /page/1/Picture/1 description: The image shows three logos. The first logo has the letters CSQ on top of the letters MED, and below that it says EN ISO 13485:2003. The second logo has the letters CSQ, and below that it says EN ISO 9001:2000. The third logo is a circle with the letters IQNet in the middle, and around the circle it says CERTIFIED MANAGEMENT SYSTEM.
- Ambu silicone resuscitator adult (K924215) ●
- Ambu silicone infant/child (K924216) ●
- . Ambu spur II adult single patient resuscitator (K042682)
- Ambu Spur II infant and paediatric single (K042843) .
Submitter: Mercury Medical
(4) Device description
Functioning and scientific concepts
A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep him oxygenated and alive. The manual resuscitators basically consist of a mask and a large hand-squeezed plastic bulb using ambient air, or supplemental oxygen.
The air and oxygen flows into the resuscitator bag.(Fig. 1, Fig. 2, Fig. 3). And compressing the bag, the patient is ventilated.
Image /page/1/Figure/14 description: The image shows two diagrams of controlled ventilation with ambient air. The first diagram, labeled "Fig. 1", shows a ventilation system with an arrow pointing to the right labeled "AIR". The text below the diagram states that without a reservoir or connection to the oxygen source, a 21% of O2 concentration is obtained. The second diagram shows a similar ventilation system, but with an arrow pointing to the right labeled "OXYGEN".
2
Image /page/2/Picture/0 description: The image shows the logo and contact information for a company called HERSILL, S.L. The logo features a stylized image of lungs. The text includes the company name, a tagline "Equipos Medicos - Medical Devices", the address "C/ Puerto de Navacerrada, 3 28935 MOSTOLES - (Madrid) - Spain", telephone and fax numbers "Tel.: +34 91 616 41 11- Fax +34 91 616 48", and website address "www.hersill.com".
Image /page/2/Picture/1 description: The image shows three logos. The first logo has the letters CSQ on top of the letters MED, and below that is the text EN ISO 13485:2003. The second logo has the letters CSQ, and below that is the text EN ISO 9001:2000. The third logo is a circle with the text CERTIFIED on top and MANAGEMENT SYSTEM on the bottom, and in the center is the text IQNet.
Image /page/2/Figure/3 description: This image shows two diagrams of controlled ventilation systems with supplemental oxygen. The top diagram shows a system without an extension tube, while the bottom diagram shows a system with an extension tube that is corrugated and 90 cm long. The text indicates that the use of additional O2 allows for an adjustable concentration from 21 up to 100%, and the use of the reservoir allows a saving of O2 upper than 50%.
In order not to apply a high pressure to the patient's airways, the resuscitators include a pressure-limiting valve.
- . Child/infant resuscitators: the pressure-limiting valve is set to open at 45 cm H2O. If higher pressures are required, press to block (no lock)
- Adult resuscitators: the pressure-limiting valve is set to open at 60 cm H2O. if . higher pressures are required, press and turn to lock
Components (Fig. 8):
- Reservoir bag -
- Reservoir valve -
- Beg inlet valve .
- Resuscitator Bag -
- Patient valve -
- Pressure-limiting valve .
3
Image /page/3/Picture/0 description: The image shows the logo and contact information for Hersill, S.L. The logo features a stylized graphic to the left of the company name, which is written in bold, black letters. Below the name, it says "Equipos Medicos - Medical Devices", followed by the address "C/ Puerto de Navacerrada, 3, 28935 MOSTOLES (Madrid) - Spain". The image also includes the telephone and fax numbers, which are +34 91 616 41 11 and +34 91 616 48 92, respectively, as well as the website address, www.hersill.com.
Image /page/3/Picture/1 description: The image shows three logos. The first logo has the letters "CSQ" on top of the letters "MED" and the text "EN ISO 13485.2003" below. The second logo has the letters "CSQ" and the text "EN 150 9001:2000". The third logo is a circle with the text "CERTIFIED" on top, "IQNet" in the middle, and "MANAGEMENT SYSTEM" on the bottom.
Image /page/3/Figure/3 description: This image is a diagram of a bag valve mask, also known as an Ambu bag. The diagram labels the different parts of the bag valve mask in both Spanish, English, and French. The parts labeled include the pressure-limiting valve, bag inlet valve, reservoir bag, patient valve, and reservoir valve. The diagram also includes the dimensions of the patient connection port, which is 22 mm male and 15 mm female, and the figure is labeled as Fig. 8.
Technical specifications:
(1) Dimensions and weight
| Dimensions extended | 310L x 130H mm adult
257L x 103H mm child
228L x 80H mm infant |
|---------------------|----------------------------------------------------------------------|
| Dimensions folded | 125L x 90H mm adult
125L x 85H mm child |
| Weight | 341 g adult
246 g child
233 g infant |
| Total bag volume | 1700 mL adult
750 mL child
300 mL infant |
| O2 reservoir volume | 2500 mL (adult-child)
500 mL (infant) |
Environmental conditions
| Storage temperature | -40℃ to +70℃
-104°F to +158°F |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Operating temperature | -20℃ to +60℃ |
| CALL CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONS | 68°F to +140°F |
Tidal volume
4
Image /page/4/Picture/0 description: The image shows the logo and contact information for Hersill, S.L. The logo features a stylized image to the left of the company name, which is written in bold, black letters. Below the name is the text "Equipos Medicos - Medical Devices". The address is listed as C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The telephone and fax numbers are +34 91 616 41 11 and +34 91 616 48 92, respectively, and the website is www.hersill.com.
Image /page/4/Picture/1 description: The image shows three different logos. The first logo has the letters "CSQ" on top of the letters "MED", with the text "EN ISO 13485:2003" underneath. The second logo has the letters "CSQ" inside of a square, with the text "EN ISO 9001:2003" underneath. The third logo is a circle with the text "CERTIFIED MANAGEMENT SYSTEM" around the edge and the letters "IQNet" in the center.
| Maximum tidal volume | |
|---|---|
| 1000mL adult | |
| 500mL child | |
| 200mL infant |
Test specifications:
Hand: EN ISO 10651-4 C=0,05L/mbar x 2 R=2mbar/(L/s) x 2
Pressure-limiting system
Safety valve incorporated in all models (it can be locked in the adult model).
| Pressure-limiting valve | 6 kPa = 60 cm H2O (Adult) |
|---|---|
| 4,5kPa = 45 cm H2O (Child-Infant) |
Frequency of ventilation
| Max. Ventilatory
frequency
[breaths / min.] | 40 (adult)
50 (child)
90 (infant) | Test specs.:
C=0,05L/mbar x 2
R=8mbar/(L/s) x 2 |
|---------------------------------------------------|-----------------------------------------|-------------------------------------------------------|
| Max.ventilation pressure
[cmH2O] | 30 (adult)
30 (child)
20 (infant) | Test specs.:
C=0,05L/mbar x 2
R=8mbar/(L/s) x 2 |
Its freedom of rotation of 360° of the mask and the valve of the patient allows to easily ventilate from any position.
Deadspace:
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5
Image /page/5/Picture/0 description: The image shows the logo for Hersill, S.L., a medical device company. The logo includes a stylized graphic to the left of the company name. Below the name is the phrase "Equipos Medicos - Medical Devices", followed by the company's address: C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The image also includes the company's telephone and fax numbers, as well as its website address: www.hersill.com.
Image /page/5/Picture/1 description: The image contains three logos. The first logo has the letters CSQ on top of the letters MED, and the text "EN ISO 13485.2002" below. The second logo has the letters CSQ and the text "EN ISO 9001:2000" below. The third logo is a circular seal with the letters IQNet in the center and the words "CERTIFIED MANAGEMENT SYSTEM" around the edge.
Expiratory and inspiratory resistance
| Expiratory resistance | $8,8Pa = 0,09cmH_2O$ | at 5L/min. |
|---|---|---|
| $172Pa=1,76cmH_2O$ | at 50L/min. | |
| Inspiratory resistance | $36Pa = 0,37cmH_2O$ | at 5L/min. |
| $341Pa=3,48cmH_2O$ | at 50L/min. |
Connectors:
- Patient connector: 22mm male / 15mm female .
- Expiratory connector: 30mm male (PEEP/AGSS). The expiratory port is normalized to . be able to incorporate PEEP.
- Reservoir valve connector: 32 mm female .
- Reservoir bag connector: 25 mm male ◆
- . O2 Connector 5,5-8 mm conical male
Delivered oxygen concentration
| 2 | 3 | 8 | 13 | 15 | L/min | |
|---|---|---|---|---|---|---|
| Without | ||||||
| reservoir | 39 | 39 | 58 | 61 | 88 | % O2 |
| With reservoir | 98 | 98 | 98 | 100 | 100 | % O2 |
(7) Accessories:
| Ref. | ACCESORIES |
|---|---|
| 0200032 | Transport case |
| (434 g, 345 x 145 x 140 mm) | |
| 4200601 | Adult patient valve |
| 4200602 | Child / infant patient valve |
| 3200618 | Hand strap |
| 4200605 | Reservoir valve |
| 3200505 | O₂ reservoir bag 500 mL |
| (230 x 95 mm) |
6
Image /page/6/Picture/0 description: The image shows the logo and contact information for a company called HERSILL, S.L. The logo includes a stylized image of lungs. The text includes the company name, a description of their products as "Equipos Medicos - Medical Devices", their address as "C/ Puerto de Navacerrada, 3 28935 MOSTOLES - (Madrid) - Spain", their telephone and fax numbers as "Tel.: +34 91 616 41 11- Fax +34 91 616 48 92", and their website as "www.hersill.com".
Image /page/6/Picture/1 description: The image shows three logos. The first logo has the letters CSQ and MED stacked on top of each other, with the text "EN ISO 13485:2003" underneath. The second logo has the letters CSQ, with the text "EN ISO 9001:2000" underneath. The third logo is a circular logo with the letters IQNet in the center and the words "CERTIFIED MANAGEMENT SYSTEM" around the edge.
| 3200504 | O₂ reservoir bag 2500 mL
(285 x 135 mm) |
|---------|--------------------------------------------|
| 3200010 | O₂ pipe extension (2 m) |
| 0200045 | Silicone mask nº 5 |
| 0200044 | Silicone mask n° 4 |
| 0200043 | Silicone mask nº 3 |
| 0200042 | Silicone mask n° 2 |
| 0200041 | Silicone mask nº 1 |
| 0200040 | Silicone mask n° 0 |
| 3200501 | PEEP valve 2-10 cmH₂O |
| 3200502 | PEEP valve 5-20 cmH₂O |
| 0132044 | Bacterial/viral filter |
| 0132045 | Membranes filter sterile (x 40) |
| 4200606 | Air way manometer |
| 0140015 | Holder ring for head strap |
| 0131344 | Head strap wring |
| 3200619 | Adapt.M22 / M23 |
| 0132108 | Extension tube corrugated (90 cm) |
| 3200621 | Adapt. F30-F32 AGSS/reservoir |
| 4200603 | Repairing kit |
| 0200049 | Cover mask (adult, child) |
| 0200048 | Cover mask (infant) |
Materials
| | Revivator
Plus | Revivator
Res-Q |
|-----------------------------------|-----------------------|-----------------------|
| Transport case | PP
(polypropylene) | PP
(polypropylene) |
| Transparent resuscitator
parts | PSU
(polysulfone) | PC
(polycarbonate) |
| Resuscitator bag | SI (silicone) | SI (silicone) |
| Valve's membranes | SI (silicone) | SI (silicone) |
| Relief valve spring | Stainless Steel | Stainless Steel |
| Relief valve closing | SI (silicone) | SI (silicone) |
| Mask | SI (silicone) | PVC |
| o-rings | Viton® | Viton® |
| Hand strap | Silicone | Silicone |
| Reservoir bag | PVC | PVC |
| O2 pipe extension (2 m) | PVC | PVC |
7
Image /page/7/Picture/0 description: The image shows the logo for Hersill, S.L., a company that specializes in medical devices. The logo includes a graphic of a medical device on the left and the company name in bold letters on the right. Below the company name is the company's address, which is C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The image also includes the company's telephone and fax numbers, which are +34 91 616 41 11 and +34 91 616 48 5, respectively, as well as the company's website address, which is www.hersill.com.
Image /page/7/Picture/1 description: The image contains three logos. The first logo has the letters CSQ on top of the letters MED, with the text EN ISO 13485:2003 below. The second logo has the letters CSQ inside of a square, with the text EN ISO 9001:2000 below. The third logo is a circle with the text CERTIFIED MANAGEMENT SYSTEM and the letters IQNet inside.
| PEEP valve
Adapt.M22 / M23 | PSU+SI+S.Steel
PA-66
(polyamide) | PSU+SI+S.Steel
PA-66
(polyamide) |
|--------------------------------|--------------------------------------------------|--------------------------------------------------|
| Extension tube
corrugated | SI (silicone) | SI (silicone) |
| Adapt.F30-32
AGSS/reservoir | PA-66
(polyamide) | PA-66
(polyamide) |
| Bacterial/viral filter | PSU
(polysulfone) | PSU
(polysulfone) |
| Holder ring for head
strap | Stainless Steel | Stainless Steel |
| Head strap wring | Isopren
(latexfree)
Autoclavable
134 °C | Isopren
(latexfree)
Autoclavable
134 °C |
| Cover mask | PSU | PSU |
(5) Intended use.
The Revivator resuscitator is intended for pulmonary resuscitation. The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs) The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs) The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
(6) Technological characteristics comparison
Comparing with the predicate devices, there are no substantial changes or modifications.
Intended use:
Both Revivator resuscitators, Ambu and Mercury Medical resuscitators are intended for pulmonary resuscitator.
Indications for use:
The different models are indicated for different people according to their weight.
8
Image /page/8/Picture/0 description: The image shows the logo for HERSIL, S.L., a company that specializes in medical devices. The logo includes a stylized graphic to the left of the company name. Below the name is the phrase "Equipos Medicas - Medical Devices", followed by the company's address: C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The image also includes the company's telephone and fax numbers, as well as its website address: www.hersill.com.
Image /page/8/Picture/1 description: The image contains three logos. The first logo is for CSQ MED EN ISO 13485:200. The second logo is for CSQ EN ISO 9001:2000. The third logo is for IQNet CERTIFIED MANAGEMENT SYSTEM.
All adult resuscitators are intended for people with a body weight of more than 30 kg (66 lbs).
Revivator and Mercury medical child resuscitators and are for children with a body weight between 7 and 30 kg (15-66 lbs) and infant resuscitators are for people with a body weight up to 7 kg.
However, Ambu child resuscitator are for people with a body weight between 10 and 30 kg and neonate or infant resuscitators are for neonates or infants with a body weight up to 10 kg.
The limit of 7 kg (Revivator resuscitators and Mercury medical resuscitators) or 10 kg (Ambu resuscitators) are not important to classify a resuscitator. Nevertheless, the mass is important for other requirements of ISO 10651-4:2002 (See Pressure limiting valve, maximum tidal volume and dead space comparison)
Standards
Revivator and Ambu resuscitators have been designed and manufactured according to ISO 10651-4:2002 : Lung ventilators . Part 4 :: Particular requirements for operator-powered resuscitators.
Moreover, Revivator and Ambu are in conformity with the Medical Devices Directive 93/42/EEC.
Mercury medical resuscitators meet ASTM F 920-93 and ISO 8382 requirements. Nevertheless, ASTM F920-93 has been withdrawn and ISO 8382 was revised by ISO 10651-4:2006.
Main materials and sterilization process:
The materials used for the manufacturing of resuscitators determine the resuscitator shelf life.
In this way, we can compare Revivator Plus and Res-Q with Ambu silicone Plus resuscitators and Mercury Medical reusable resuscitators.
The main material of Revivator resuscitator is silicone (bag and valves). Depending on the model, the rest of plastic pieces are made of polisulfone (Revivator Plus), or policarbonate (Revivator Res-Q).
9
Image /page/9/Picture/0 description: The image shows the logo for HERSIL, S.L., a company that specializes in medical devices. The logo includes a graphic of a medical device on the left and the company name in bold letters on the right. Below the company name is the company's address, which includes the street name, city, and postal code. The image also includes the company's telephone and fax numbers, as well as its website address.
Image /page/9/Picture/1 description: The image shows three logos. The first logo has the letters CSQ on top of the letters MED, with the text EN ISO 13485 2003 underneath. The second logo has the letters CSQ with the text EN ISO 9001:2000 underneath. The third logo is a circle with the text CERTIFIED MANAGEMENT SYSTEM around the edge and the letters IQNet in the center.
The shelf life and the reuse of resuscitators depends on the plastic material. Polisulfone pieces can be sterilized at 135 ℃ and polycarbonate pieces at 121℃.
The design of Revivator Plus and Revivator Res-Q is the same, but the plastic pieces of Revivator Res-Q are made of polycarbonate (PC) instead of polysulfone (PSU). Polycarbonate pieces are completely safe. The difference is the material resistance to heat. So, PC pieces cannot be sterilized at temperatures higher than 121ºC.
Ambu silicone resuscitators and Mercury Medical resuscitators are also made of silicone (bag and valves) and polisulfone (the rest of plastic pieces). So they can be also sterilized at 134℃.
Both Ambu silicone resuscitator and Revivator Plus has reservoir bags made of PVC and silicone oxygen masks. Moreover, the PVC bag and the silicone masks included in Revivator resuscitators have been also biocompatibility tested.
Regarding Mercury Medical disposable resuscitators, the materials are unknown, since they are not included in their labeling.
Revivator Res-Q includes single use oxygen mask (PVC masks). Ambu Spur II also offers disposable oxygen masks. PVC masks included in Revivator Res-Q has been also biocompatibility tested.
Dimensions and weight
10
Image /page/10/Picture/0 description: The image shows the logo and contact information for a company called HERSILL, S.L. The logo features a stylized graphic to the left of the company name. Below the name is the text "Equipos Medicos - Medical Devices", followed by the address "C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain". The phone and fax numbers are listed as "Tel.: +34 91 616 41 11-Fax +34 91 616 48", and the website is "www.hersill.com".
Image /page/10/Picture/1 description: The image contains three logos. The first logo has the letters CSQ on top of the letters MED, and the text "EN ISO 13485:2003" below. The second logo has the letters CSQ and the text "EN 150 9001.2000" below. The third logo is a circle with the text "CERTIFIED" on top, the logo IQNet in the middle, and the text "MANAGEMENT SYSTEM" on the bottom.
All resuscitators have similar dimensions and weights. The lower dimensions and weight of neonate/infant Ambu resuscitators (see table) is due to that they do not include the weight of the mask and the dimension of the reservoir bag.
Storage and operating temperatures
Storage and operating temperatures are similar for all resuscitators but, the operating temperature for Ambu Spur II is up to 60℃ instead of 70℃. This is due to Ambu Spur II use some materials such us SEBS and polyethylene that have lower resistance to temperatures.
Maximum tidal volume and total bag volume
The total bag volume is in relation with the maximum tidal volume. So the maximum tidal volume is the parameter to compare.
According to ISO the maximum tidal volume shall be at least:
- 150 mL for resuscitators for people with a body weight lower than 10 kg ●
- 450 mL for resuscitators for people with a body weight between 10 and 40 kg .
- 600 mL for resuscitators for people with a body weigh higher than 40 kg .
Therefore, all resuscitators are according to this standard.
02 reservoir volume
The reservoir volume is in relation with the delivery oxygen concentration when using supplemental oxygen. ISO 10651-4:2002 requires that resuscitators supplied an oxygen concentration at least 85%. (V/V)
As Revivator and Ambu resuscitators are in conformity with this standard, the reservoir volumes (2500-2600 mL or 300-500 mL) are appropriate to meet this requirement. Mercury Medical resuscitators have also similar 02 reservoir volumes
Moreover, 2500 mL or 2600 mL are common values for adult reservoir bags and 600, 500 and 300 mL are commonly used for infant resuscitators.
Pressure-limiting valve
11
Image /page/11/Picture/0 description: The image shows the logo for Hersill, S.L., a medical device company. The logo includes a stylized graphic to the left of the company name. Below the name is the text "Equipos Medicos" and "Medical Devices". The address is listed as C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain, followed by the telephone number +34 91 616 41 11, the fax number +34 91 616 48, and the website www.hersill.com.
Image /page/11/Picture/1 description: The image shows three logos. The first logo has the letters CSQ and MED stacked on top of each other, with the text "EN ISO 13485:2003" below. The second logo has the letters CSQ in a square, with the text "EN ISO 9001:2000" below. The third logo is a circle with the text "CERTIFIED" at the top and "MANAGEMENT SYSTEM" at the bottom, with the letters IQNet in the center.
The ISO 10651-4:2002 says that all resuscitators intended for use with people with a body weight lower than 10 kg shall have a pressure limitation system. The pressure shall not be higher than 4.5 kPa.
Revivator resuscitators for child and infants has a pressure limiting valve at 4.5 kPa Ambu silicone resuscitators and Ambu Spur II for child and infant has also a pressure limiting valve at 4.0 kPa.
Mercury medical resuscitators (child and infant models) have also a pressure-limiting valve at 4.0 ± 0.5 kPa
Both 4.5 kPa and 4.0 kPa are admissible according to the standard. So they can be considered safe and equivalent.
Revivator resuscitaros for adults also include a pressure limiting valve at 6 kPa and Ambu Spur II has also available a pressure limiting valve at 4,0 kPa. Mercury medical resuscitators have also an optional pressure limiting valve for small adults
ISO 10651-4:2002 considers this option for resuscitators for people with a body weight higher than 10 kg. The pressure shall be lower than 6 kPa. Therefore both resuscitators meet ISO 10651-4:2002 and they can be considered as safe devices.
Dead space of patient valve
The dead space for Revivator is lower than 7 mL. The predicate devices has a dead space lower between 5 and 7 mL.
The differences of the dead space between Revivator, Ambu and Mercury Medical do not raise safety concerns, since according to the ISO 10651-4:2002 the apparatus dead space shall not exceed 5 mL +10 % of the minimum delivered volume.
| According to Table 1, ISO 10651-4:2002 | Deadspace |
|---|---|
| B 40, Vdel=600mL | 65 mL |
Therefore, values lower than 7 ml of dead space for Revivator resuscitators are completely admissible and it does not affect the safety and effectiveness of the resuscitators.
12
Image /page/12/Picture/0 description: The image shows the logo for Hersill, S.L., a company that produces medical devices. The logo includes an emblem to the left of the company name. Below the company name is the text "Equipos Medicos - Medical Devices", followed by the company's address: C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The image also includes the company's telephone and fax numbers, as well as its website address.
Image /page/12/Picture/1 description: The image contains three logos. The first logo is for CSQ MED EN ISO 13485:2003. The second logo is for CSQ EN ISO 9001:2000. The third logo is a circular logo for IQNet Certified Management System.
Expiratory resistance
According to ISO 10651-4:2002, the expiratory resistance shall not exceed 5 cm H2O
Revivator, Ambu and Mercury Medical resuscitators have values much lower than the admissible value.
Moreover, to facilitate exhalation, expiratory resistance should be minimized. Since Revivator resuscitators have lower expiratory resistance than predicate devices, Revivator resuscitators facilitate a better exhalation comparing with the predicate devices
Inspiratory resistance
According to ISO 10651-4:2002, the inspiratory resistance shall not exceed 5 cm H2O below atmospheric pressure.
Revivator, Ambu and Mercury Medical resuscitators have values much lower than the admissible or in the case of Ambu Spur II (adult and pediatric resuscitators) which have an inspiratory resistance of 5 cm H20 at 50 1/min
The design of the resuscitator should be such that it is possible for the patient to breathe spontaneously without excessive subatmospheric pressure when the resuscitator is applied to the patient's airway.
Since Revivator resuscitators have low inspiratory resistance, they let patients to breathe better spontaneously than predicate devices.
Patient and expiratory connector
The patient and expiratory connectors are described in ISO 10651-4:2002.
Both Revivator and Ambu resuscitators are in conformity with this standard:
- patient connectors : 22/15 mm
- expiratory connectors: 30 mm male
Mercury Medical don not include information on connectors in the labeling.
Applications
2.1. Controlled ventilation with ambient air: without reservoir nor connection to the oxygen source, at 21% of O2 concentration is obtained.
2.2. Controlled ventilation with supplemental oxygen with or without reservoir: the use of additional O2 allows to obtain an adjustable concentration from 21 up to 100%,
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Image /page/13/Picture/0 description: The image shows the logo and contact information for Hersill, S.L. The logo features a stylized image of lungs. The text includes the company name, "HERSILL, S.L.," followed by "Equipos Medicos - Medical Devices." The address is listed as C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain, and the telephone and fax numbers are +34 91 616 41 11 and +34 91 616 48 9, respectively. The website address is www.hersill.com.
Image /page/13/Picture/1 description: The image shows three logos. The first logo is for CSQ MED EN ISO 13485:2003. The second logo is for CSQ EN ISO 9001:2000. The third logo is for IQNet CERTIFIED MANAGEMENT SYSTEM.
according to the flow of the O2 source. This is the recommended practise by all the actual resuscitation guidelines. The use of the reservoir allows a saving of O2 upper than 50%.
Both applications are available for all resuscitators.
Ambu resuscitators also include the ventilation with a face mask and the oxygen administration (instructions for use, point 5)
Mercury medical resuscitators consider these applications in several sentences included in its instructions:
Precautions- 3- If used with supplemental oxygen ( ... )
Directions for use-6- when a bag reservoir is being used ( ... )
In addition the ISO 10651-4 allows an attachment to reach high concentration of oxygen
3. Other recommended configurations
- 3.1.System of fixation of the mask to the head (head strap wring): It is recommended during the anesthesia, prolonged controlled ventilation, spontaneous ventilation with O2 inhalation and during the transport of the patient; thanks to the design of the provided masks, a slight pressure is enough to obtain a perfect seal with the face.
Although the face mask provides a perfect seal with the face mask, it is available a head strap wring.
This configuration is not included in the predicate devices. This is a useful accessory for the rescuer in order to have a system of fixation of the mask to the head specially when patients have to be transported.
- 3.2. Ventilation with PEEP: The expiratory port is a 30 mm conical male apt for the connection of any standardized PEEP valve.
Ambu reusable resuscitators also include an expiratory connector for PEEP valve (direction for use- point 3 .- specifications and point 12- accessories)
Mercury medical resuscitators consider this configuration their directions of use-point 9 : "The patient valve features a built-in PEEP Adapter Port ( ... )"
In addition ISO 10651-4 allows an expiratory port of 30 mm.
- 3.3.Airway pressure manometer: By means of Fig. 7 assembly the air-way pressure; this control is very important when the patient is ventilated with the pressure-limiting valve
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Image /page/14/Picture/0 description: The image shows the logo for Hersill, S.L., a medical device company. The logo includes a stylized graphic to the left of the company name. Below the name, it says "Equipos Medicos - Medical Devices". The address is listed as C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The phone number is +34 91 616 41 11 and the fax number is +34 91 616 48, and the website is www.hersill.com.
Image /page/14/Picture/1 description: The image contains three logos. The first logo has the letters CSQ and MED stacked on top of each other, with the text "EN ISO 13485 2323" underneath. The second logo has the letters CSQ inside of a square, with the text "EN 150 9001:2000" underneath. The third logo is a circular seal with the letters IQNet in the center and the words "CERTIFIKO" and "MANAGEMENT SISTEM" around the edge.
.
.
blocked, or when it is coupled a PEEP valve or a system of breathed anesthetic gas evacuation.
A pressure gauge is also available for Ambu resuscitators. Direction for use, point 5.1 : " A pressure gauge can be connected to the tube connector on the side of the patient valve for monitoring ventilation pressure"
Mercury medical resuscitators consider this configuration their directions of use-point 4 and 9 : "The use of an airway pressure manometer is recommended ( ... )" and " When adjusting the Mercury Medical PEEP Valve, connect a manometer in line ( ... )"
Bag refill valve connectors
According to ISO 10651-4:2002, it shall be a 32 mm female conical connector.
The connector of Revivator resuscitators is a 32 mm female connector and the predicates are also in conformity with ISO 10651-4:2002/ ISO 8382, so they shall be 32 mm female conical connector, although it is not included in their labelling. The standards ISO10651-4/1SO8382 do not require this information to be included in the labelling.
Dismantling and reassembly
All resuscitators intended to be reused and dismantled by the user includes in their labelling a functional test of operation to be carried out after reassembly
Patient Valve function after contamination with vomitus
All resuscitators are in conformity with ISO 10651-4/1SO8382. The standards ISO10651-4/1SO8382 do not require this information to be included in the labelling.
Drop test
All resuscitators are in conformity with ISO 10651-4/ISO8382. The standards ISO10651-4/1SO8382 do not require this information to be included in the labelling.
Immersion in water
All resuscitators are in conformity with ISO 10651-4/ISO8382. The standards ISO10651-4/1SO8382 do not require this information to be included in the labelling.
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Image /page/15/Picture/0 description: The image shows the logo for Hersill, S.L., a medical device company. The logo includes a stylized graphic to the left of the company name. Below the name is the text "Equipos Medicos - Medical Devices", followed by the company's address: C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The image also includes the company's telephone and fax numbers, +34 91 616 41 11 and +34 91 616 48, respectively, as well as their website address, www.hersill.com.
Image /page/15/Picture/1 description: The image contains three logos. The first logo has the letters CSQ on top of MED, with the text EN ISO 13485.2003 below. The second logo has the letters CSQ with the text EN ISO 9001:2000 below. The third logo is a circle with the word CERTIFIED on top, IQNet in the middle, and MANAGEMENT SYSTEM on the bottom.
Supplementary_oxygen and delivered concentration
Resuscitators shall deliver a minimum oxygen concentration of at least 35% (V/V) when connected to an oxygen source supplying not more than 151/min and shall be capable of delivering at least 85%(V/V). the 85% may be accomplished with the use of an attachment. The manufacturer shall state the range of concentrations at representative flows.
Considering the test conditions (C20, R20, 12 bpm and 600 mL), all resuscitators deliver the minimum oxygen concentration.
Expiratory resistance
According to ISO 10651-4:2002, the expiratory resistance shall not exceed 5 cm H2O
Revivator, Ambu and Mercury Medical resuscitators have values much lower than the admissible value.
Moreover, to facilitate exhalation, expiratory resistance should be minimized. Since Revivator resuscitators have lower expiratory resistance than predicate devices, Revivator resuscitators facilitate a better exhalation comparing with the predicate devices
Inspiratory resistance
According to ISO 10651-4:2002, the inspiratory resistance shall not exceed 5 cm H2O below atmospheric pressure.
Revivator, Ambu and Mercury Medical resuscitators have values much lower than the admissible or in the case of Ambu Spur II (adult and pediatric resuscitators) which have an inspiratory resistance of 5 cm H20 at 50 1/min
The design of the resuscitator should be such that it is possible for the patient to breathe spontaneously without excessive subatmospheric pressure when the resuscitator is applied to the patient's airway.
Since Revivator resuscitators have inspiratory resistance, they let patients to breathe better spontaneously than predicate devices.
Patient valve malfunction
All resuscitators are in conformity with ISO 10651-4/ISO8382.
16
Image /page/16/Picture/0 description: The image shows the logo and contact information for a company called HERSILL, S.L. The logo features a stylized image of lungs. The text includes the company name, a description of their products as "Equipos Medicos - Medical Devices", and their address as C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The phone and fax numbers are +34 91 616 41 11 and +34 91 616 48 9, respectively, and their website is www.hersill.com.
Image /page/16/Picture/1 description: The image contains three logos. The first logo has the letters "CSQ" on top of the letters "MED" and the text "EN ISO 13435 2003" below. The second logo has the letters "CSQ" and the text "EN ISO 9001:2000" below. The third logo is a circular seal with the letters "IQNet" in the center and the words "CERTIFIED MANAGEMENT SYSTEM" around the edge.
The standards ISO10651-4/1SO8382 requires to include in the instructions for use the value of end-expiratory pressure generated by the resuscitator in normal use, if greater than 0.2 kPa. In addition the pressure gradient shall be lower than 0.6 kPa
There is not an increase in the pressure gradient at the end of expiration at 30 L/min in Revivator resuscitators.
As the value of the end -expiratory pressure generated in not included in the instructions of the predicate devices, it is expected to be lower than 0.2 kPa. Therefore predicate devices are also in conformity with the standard.
Apparatus deadspace. Dead space of patient valve
The dead space for Revivator is lower than 7 mL. The predicate devices has a dead space lower between 5 and 7 mL.
The differences of the dead space between Revivator, Ambu and Mercury Medical do not raise safety concerns, since according to the ISO 10651-4:2002 the apparatus dead space shall not exceed 5 mL +10 % of the minimum delivered volume.
| According to Table 1, ISO 10651-4:2002 | Deadspace | |
|---|---|---|
| B 40, Vdel=600mL | 65 mL |
Therefore, values lower than 7 ml of dead space for Revivator resuscitators are completely admissible and it does not affect the safety and effectiveness of the resuscitators.
Maximum tidal volume
According to ISO the maximum tidal volume shall be at least:
- 150 mL for resuscitators for people with a body weight lower than 10 kg .
- 450 mL for resuscitators for people with a body weight between 10 and 40 kg .
- 600 mL for resuscitators for people with a body weigh higher than 40 kg .
Therefore, all resuscitators are according to this standard.
Pressure-limiting valve
The ISO 10651-4:2002 says that all resuscitators intended for use with people with a body weight lower than 10 kg shall have a pressure limitation system.
17
Image /page/17/Picture/0 description: The image shows the logo and contact information for a company called HERSILL, S.L. The logo features a stylized graphic to the left of the company name. Below the name, it says "Equipos Medicos - Medical Devices." The address is listed as C/ Puerto de Navacerrada, 3, 28935 MOSTOLES - (Madrid) - Spain. The telephone number is +34 91 616 41 11, and the fax number is +34 91 616 48. The website address is www.hersill.com.
Image /page/17/Picture/1 description: The image contains three logos. The first logo has the letters "CSQ" on top of the letters "MED", with the text "EN ISO 13485:2012" underneath. The second logo has the letters "CSQ" with the text "EN ISO 9001:2000" underneath. The third logo is a circular logo with the letters "IQNet" in the center and the words "CERTIFIKA MANAGEMENT SYSTEM" around the edge.
The pressure shall not be higher than 4.5 kPa.
Revivator resuscitators for child and infants has a pressure limiting valve at 4.5 kPa Ambu silicone resuscitators and Ambu Spur II for child and infant has also a pressure limiting valve at 4.0 kPa.
Mercury medical resuscitators (child and infant models) have also a pressure-limiting valve at 4.0 ± 0.5 kPa
Both 4.5 kPa and 4.0 kPa are admissible according to the standard. So they can be considered safe and equivalent.
Revivator resuscitaros for adults also include a pressure limiting valve at 6 kPa and Ambu Spur II has also available a pressure limiting valve at 4,0 kPa. Mercury medical resuscitators have also an optional pressure limiting valve for small adults
ISO 10651-4:2002 considers this option for resuscitators for people with a body weight higher than 10 kg. The pressure shall be lower than 6 kPa. Therefore both resuscitators meet ISO 10651-4:2002 and they can be considered as safe devices.
Storage conditions
The resuscitator shall after storage at temperatures of -40°C and +60°C and at any relative humidity between 40% and 95% meet the general and specific requirements specified in the standard.
All resuscitators meet these storage conditions. In addition Revivator and Ambu reusable resuscitators can be also storaged at 70℃ because of the materials have been selected to be reused and sterilized.
Operating conditions
Resuscitators shall meet the requirements specified in the standard throughout the temperature range from -18°C to +50°C and a humidity range from 40% to 95% r.h.
All resuscitators meet these operating conditions. In addition Revivator and Ambu reusable resuscitators can be also used at -20℃.
CONCLUSIONS
Considering the similarities and that the small differences are justified by the standard ISO 10651-4:2002, REVIVATOR resuscitators can be considered equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ana Maria Romero Quality Assurance Hersill, S. L. Puerto De Navacerrada, 3 Mostoles (Madrid) Spain 28935
SEP 1 7 2010
Re: K094003
Trade/Device Name: Revivator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: September 10, 2010 Received: September 10, 2010
Dear Ms. Romero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
19
Page 2- Ms. Romero
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
James A. Todd
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/20/Picture/0 description: The image shows the logo for HERSIL, S.L., a company that specializes in medical devices. The logo includes a stylized image of lungs and the company name in bold, black letters. Below the name is the phrase "Equipos Medicos - Medical Devices." The image also includes the company's address, phone and fax numbers, and website address.
Image /page/20/Picture/1 description: The image contains three logos. The first logo has the letters CSQ on top of the letters MED, with the text EN ISO 13455:2003 underneath. The second logo has the letters CSQ with the text EN ISO 9001:2000 underneath. The third logo is a circle with the text CERTIFIED MANAGEMENT SYSTEM around the edge and the letters IQNet in the center.
- INDICATIONS FOR USE STATEMENT
(094003
Indications for Use
SEP 1 7 2010
510(k) Number (if known): _ Device Name: REVIVATOR Indications for Use:
The Revivator resuscitator is intended for pulmonary resuscitation.
The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs) The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs)
The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_of _1
L. Schutthe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KOQUOO3 510(k) Number:
(Posted November 13, 2003)