(60 days)
Not Found
No
The document describes a physical face mask for noninvasive ventilation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a mask intended to provide a patient interface for noninvasive ventilation, specifically as an accessory to ventilators for the treatment of respiratory conditions. While it is used with therapeutic devices, the mask itself is a patient interface, not the primary therapeutic device.
No
The device is a face mask intended to provide a patient interface for noninvasive ventilation, acting as an accessory to ventilators. Its purpose is to deliver therapy (CPAP or positive pressure ventilation), not to diagnose conditions.
No
The device description clearly describes a physical face mask and associated hardware components (headgear, elbow), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AF531 Oro-Nasal SE Face Mask is a patient interface used to deliver noninvasive ventilation. It's a physical device that connects a patient to a ventilator.
- Intended Use: The intended use clearly states it's for "providing a patient interface for application of noninvasive ventilation" and is an "accessory to ventilators." It does not involve testing samples from the body.
The information provided describes a medical device used for respiratory support, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.
The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.
The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Small Size: patients 7 years or older
Medium and Large Size: patients (>30 kg)
Intended User / Care Setting
hospital/institutional environment
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)
Non-clinical verification testing completed for the new device demonstrated that the AF531 Oro-Nasal SE Face Mask with click-style elbow met all intended performance requirements. These include:
- Total Mask Leak
- Pressure Drop Closed to Atmosphere
- Sound Testing and Pressure Level
- Physical Dead Space
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.
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 30, 2024
Respironics, Inc. Gary LeMere Principal Regulatory Affairs Specialist 1001 Murry Ridge Ln Murrysville, Pennsylvania 15668
Re: K243394
Trade/Device Name: AF531 Oro-Nasal SE Face Mask Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: October 31, 2024 Received: October 31, 2024
Dear Gary Lemere:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
AF531 Oro-Nasal SE Face Mask
Indications for Use (Describe)
Medium and Large Size:
The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size:
The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kq) who are appropriate candidates for noninvasive ventilation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary – K243394
| Date Prepared | December 27, 2024 |
|---|---|
| Company Name/ Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 733-0200 | |
| Official Contact | Gary LeMere |
| Principal Regulatory Affairs Specialist | |
| Proprietary Name(s) | AF531 Oro-Nasal SE Face Mask |
| Common/Usual Name | Oro-Nasal Face Mask |
| Classification | Class II |
| Product Code | CBK - ventilator, continuous, facility use |
| Regulation Name | Continuous ventilator |
| Regulation Number | 21 CFR 868.5895 |
| Review Panel | Anesthesiology |
| Primary Predicate Device | |
| 510(k) | |
| Product Code | AF541 SE Full Face Mask |
| K150638 | |
| CBK | |
| Secondary Predicate Device | |
| 510(k) | |
| Product Code | AF531 SE Full Face Mask |
| K101129 | |
| CBK |
5
Device Description
The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.
The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.
The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.
Indications for Use
AF531 Oro-Nasal SE Face Mask
Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.
| Design
Parameter or
Feature | Subject Device:
AF531 Oro-Nasal SE Face
Mask | Primary Predicate:
AF541 SE Full Face Mask
K150638
(September 18, 2015) | Secondary Predicate:
AF531 SE Full Face Mask
K101129
(September 16, 2010) | Comments |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | | Intended Use | Intended Use | |
| Classification
Product Code | CBK | CBK | CBK | Identical |
| Regulation
Number | 21 CFR§ 868.5895 | 21 CFR§ 868.5895 | 21 CFR§ 868.5895 | Identical |
| Classification | II | II | II | Identical |
| Indications for
Use | Medium and Large:
The AF531 Oro-Nasal SE
Face Mask is intended to
provide a patient interface
for application of
noninvasive ventilation. The
mask is to be used as an
accessory to ventilators
which have adequate alarms
and safety systems for
ventilation failure, and which | The AF541 SE Full Face
Mask is intended to provide
a patient interface for
application of noninvasive
ventilation. The mask is to
be used as an accessory to
ventilators which have
adequate alarms and safety
systems for ventilation
failure, and which are | The AF531 SE Full Face
Mask is intended to
provide a patient interface
for application of
noninvasive ventilation.
The mask is to be used as
an accessory to ventilators
which have adequate
alarms and safety systems
for ventilation failure, and | Equivalent |
| Design
Parameter or
Feature | Subject Device:
AF531 Oro-Nasal SE Face
Mask with click-style elbow | Primary Predicate:
AF541 SE Full Face Mask
K150638
(September 18, 2015) | Secondary Predicate:
AF531 SE Full Face Mask
K101129
(September 16, 2010) | Comments |
| | are intended to administer
CPAP or positive pressure
ventilation for treatment of
respiratory failure,
respiratory insufficiency or
obstructive sleep apnea.
The mask is for single use in
the hospital/institutional
environment only. The mask
is to be used on patients
(>30 kg) who are
appropriate candidates for
noninvasive ventilation.
Small:
The AF531 Oro-Nasal SE
Face Mask is intended to
provide a patient interface
for application of
noninvasive ventilation. The
mask is to be used as an
accessory to ventilators
which have adequate alarms
and safety systems for
ventilation failure, and which
are intended to administer
CPAP or positive pressure
ventilation for treatment of
respiratory failure,
respiratory insufficiency or
obstructive sleep apnea.
The mask is for single use in
the hospital/institutional
environment only. The mask
is to be used on patients 7
years or older (>20 kg) who
are appropriate candidates
for noninvasive ventilation. | intended to administer
CPAP or positive pressure
ventilation for treatment of
respiratory failure,
respiratory insufficiency or
obstructive sleep apnea.
The mask is for single use
in the hospital/ institutional
environment only. The
mask is to be used on
patients (>40lbs/20kg) who
are appropriate candidates
for noninvasive
ventilation. | which are intended to
administer CPAP or
positive pressure
ventilation for treatment of
respiratory failure,
respiratory insufficiency, or
obstructive sleep apnea.
The mask is for single use
in the hospital/institutional
environment only. The
mask is to be used on
patients 7 years or older
(>40lbs/20kg) who are
appropriate candidates for
noninvasive
ventilation | |
| Patient
Population | Small Size: Patients >7
years (>20kg)
Medium/Large Size: >30kg | All sizes: Patients
40lbs/20kg | Small Size: Patients >7
years (>40lbs/20kg) | Equivalent |
| Functional
Indication | Interface for application of
noninvasive ventilation | Interface for application of
noninvasive ventilation | Interface for application of
noninvasive ventilation | Identical |
| Environment
of Use | Hospital/
Institutional Environment | Hospital/
Institutional Environment | Hospital/
Institutional Environment | Identical |
| Reprocessing
Claims | Single use | Single use | Single use | Identical |
| Anatomical
Sites | Nose and mouth | Nose and mouth | Nose and mouth | Identical |
| Design
Parameter or
Feature | Subject Device:
AF531 Oro-Nasal SE Face
Mask with click-style elbow | Primary Predicate
AF541 SE Full Face Mask
K150638
(September 18, 2015) | Secondary Predicate:
AF531 SE Full Face Mask
K101129
(September 16, 2010) | Comments |
| Sterile State as
Provided | Non-Sterile | Non-Sterile | Non-Sterile | Identical |
| Useful Life | ≤ 7 days | Not Defined | Not Defined | Equivalent |
| Device Design | Polycarbonate faceplate
Silicone cushion
Click-Style Elbows
SE option without
entrainment valve
Elbow retention hub to
retain click-style elbow
Headgear
Accessory Port Cap | Nylon Faceplate
Silicone cushion
Click-Style Elbows
SE option without
entrainment valve
No elbow retention hub
integral to AF541
design; elbows attach
via faceplate
Headgear
Accessory Port Cap | Polycarbonate
faceplate
Silicone cushion
Press-fit Elbows
SE option without
entrainment valve
Elbow retention hub to
retain press-fit elbow
Headgear
Pick-off Port Cap | Equivalent |
| Faceplate/
Cushion Type | Covers nose and mouth | Covers nose and mouth | Covers nose and mouth | Identical |
| Exhalation
Device Design | Separate exhalation device
required | Separate exhalation device
required | Separate exhalation device
required | Identical |
| Headgear Type | CapStrap or four-point
headgear | CapStrap or four-point
headgear | CapStrap or four-point
headgear | Identical |
| Patient Circuit
Connection | 22mm click-style elbow with
22mm connector | 22mm click-style elbow with
22mm connector | 22mm press-fit
elbow with 22mm
connector | Equivalent |
| Mask Sizes | Small, Medium, and Large | Small, Medium, Large, and
Extra-Large | Small | Equivalent |
| Materials -
Elbows | SE Click-Style Elbow:
Polypropylene (Blue)
Accessory Port Cap:
Silicone | SE Click-Style Elbow:
Polypropylene (Blue)
Accessory Port Cap:
Silicone | SE Press-Fit Elbow:
Polycarbonate (Blue)
Pick-off Port Cap:
Silicone | Identical to
Primary
predicate |
| Materials -
Mask and
Headgear
Component | Mask Materials:
Faceplate:
Polycarbonate/polysiloxane
Cushion: Polysiloxane
Click-Style Elbow Hub:
Polycarbonate
Split Washer: Polycarbonate
Forehead Arm:
Polycarbonate/ polysiloxane
Support Retaining Clip:
Polycarbonate
Forehead Bracket:
Polycarbonate/
polysiloxane
Disposable Foam Forehead
Spacer: Polyurethane foam | Mask Materials:
Faceplate: Nylon
Over the nose / under the
nose Cushion: Silicone
Over the Nose / under the
nose Hub: Nylon
Headgear Materials:
4 Point Crown Headgear
Materials:
Forehead Pad Bracket:
Nylon
Forehead Adjuster Ball
Post:
Nylon
Forehead Adjuster Button:
Nylon
Disposable Foam Forehead
Spacer:
Polyurethane | Mask Materials:
Faceplate: Polycarbonate/
polysiloxane
Cushion: Polysiloxane
Press-Fit Elbow Hub:
Polycarbonate
Split Washer:
Polycarbonate
Forehead Arm:
Polycarbonate/
polysiloxane
Support Retaining Clip:
Polycarbonate
Forehead Bracket:
Polycarbonate/
polysiloxane
Disposable Foam
Forehead Spacer:
Polyurethane foam | Equivalent |
| Design
Parameter or | Subject Device:
AF531 Oro-Nasal SE Face | Primary Predicate
AF541 SE Full Face Mask | Secondary Predicate:
AF531 SE Full Face Mask | Comments |
| Feature | Mask with click-style elbow | K150638
(September 18, 2015) | K101129
(September 16, 2010) | |
| | | Headgear Clip:
Polypropylene,
Tension Clip:
Polyoxymethylene
Velcro Hook: Nylon
Headgear Material: Nylon
Polyester Polyurethane,
Nylon | | |
| | CapStrap Materials:
CapStrap Halo: Nylon
CapStrap Soft Goods:
Nylon, Polyester/
Polyurethane,
Polyester/Lycra Knit Elastic
CapStrap Clip:
Acetal copolymer | CapStrap Headgear:
Cap: Nylon Fabric, Foam,
Pad Bracket: Nylon
Adhesive: Loctite
Headgear Clip:
Polypropylene
Velcro Hook: Nylon | CapStrap Materials:
CapStrap Halo: Nylon
CapStrap Soft Goods:
Nylon,
Polyester/ Polyurethane,
Polyester/Lycra Knit
Elastic
CapStrap Clip:
Acetal copolymer | |
| | Headgear Materials:
Headgear Clip:
Acetal copolymer
Headgear Material: Nylon,
Lycra, Polyester/
polyurethane,
Polyoxymethylene | Headgear Material: Nylon
Polyester Polyurethane | Headgear Materials:
Headgear Clip:
Acetal copolymer.
Headgear Material: Nylon,
Lycra Polyester/
polyurethane,
Polyoxymethylene | |
| Performance Specifications | | | | |
| Pressure
Range | 4 to 40cmH2O | 4 to 40cmH2O | 4 to 40cmH2O | Identical |
| Total Mask
Leak | Specification:
≤15 SLPM@4.0cmH2O
≤25 SLPM@40.0cmH2O | SE Specification, all sizes:
≤15 SLPM@4.0cmH2O
≤25 SLPM@40.0cmH2O | Specification:
≤15 SLPM@4.0cmH2O
≤25 SLPM@40.0cmH2O | Identical |
| Pressure Drop | Specifications:
≤ 1.0cmH2O@50SLPM
≤ 4.0cmH2O@100SLPM | Specifications:
≤ 1.0cmH2O@50SLPM
≤ 4.0cmH2O@100SLPM | Specifications:
≤ 1.0cmH2O@50SLPM
≤ 4.0cmH2O@100SLPM | Identical |
| Sound Power
and Pressure
Level | Test results at 10cmH2O:
Power Level:18.2dBA@1m
Pressure
Level:10.9dBA@1m | Test results:
Power Level:16.5dBA
Pressure Level:9.4dBA | Not provided in original
submission | Equivalent |
| Deadspace
Volume (mL) | Specification:
S: