(219 days)
Not Found
No
The document describes a standard automated external defibrillator (AED) with features like a patient analysis system algorithm for shockable rhythms and a CPR meter with feedback. There is no mention of AI or ML in the description of the device's functionality or the analysis of patient data. The "SMART biphasic, impedance-compensating exponential waveform" and "multi-parameter Patient Analysis System (PAS) algorithm" are standard signal processing and algorithmic approaches, not indicative of AI/ML.
Yes
The device, an automated external defibrillator (AED) and its accessories, is intended to treat ventricular fibrillation and certain ventricular tachycardias, guide CPR, and provide ECG monitoring, all of which aretherapeutic functions.
Yes
The FR3 device itself assesses heart rhythms to determine if a shock is needed, and the optional 3-Lead ECG Cable provides a non-diagnostic ECG display and "alerts the responder if the ECG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock." While the ECG display is explicitly stated as "non-diagnostic," the device's analysis and alerting features (even if for triage rather than a definitive diagnosis) contribute to it being considered a diagnostic device.
No
The device description clearly states it is a battery-powered automated external defibrillator (AED) and lists various hardware components and accessories, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, the FR3 device itself is not an In Vitro Diagnostic (IVD).
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.
- FR3's Function: The FR3 is an automated external defibrillator (AED). Its primary function is to analyze the electrical activity of the heart in vivo (within the body) and deliver an electrical shock if a shockable rhythm is detected. It interacts directly with the patient's body via pads placed on the chest.
- Intended Use: The intended use clearly states it's for treating ventricular fibrillation and certain ventricular tachycardias by applying pads to potential victims of sudden cardiac arrest. This is a therapeutic intervention based on in vivo analysis.
- Accessories: While some accessories like the 3-Lead ECG Cable provide diagnostic information (non-diagnostic ECG display), this is still based on in vivo electrical signals from the heart, not analysis of samples taken from the body. The CPR Meter provides feedback on CPR performance, which is also not an IVD function.
Therefore, the FR3, as described, falls under the category of a therapeutic medical device that performs in vivo analysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FR3 is intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The FR3 is used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
- · Unresponsiveness
- · Absence of normal breathing
If in doubt, apply the pads.
The FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 Infant/Child Key. If the Infant/Child Kev is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.
The FR3 is intended for use by responders who have been trained in its operation and qualified by training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The FR3 can be configured under the guidance of a Medical Director to enable Advanced Use mode and alternative cardiopulmonary resuscitation (CPR) protocols, such as CPR while Armed, CPR First-User, and CPR First-Always.
WARNING: Performance of the SMART CPR AUTOI and AUTO2 settings for the CPR First feature has not been established in patients under 55 1b (25 kg) or 8 years old.
CPR Meter with Q-CPR
The FR3 can be used with the optional CPR meter with Q-CPR® technology by Laerdal. The system is designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter.
WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lb (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled.
When attached to the bare chest of a suspected victim of SCA and connected to an FR3 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 alerts the responder when it detects hyperventilation (more than 12 ventilations per minute) of the patient during CPR.
3-Lead ECG Cable
In addition, at the discretion of a responder trained in its use, the optional FR3 3-Lead ECG Cable can be connected to the FR3 ECG model to provide a non-diagnostic ECG display of the heart rhythm of a patient who is responsive and breathing normally but at risk of cardiac distress. The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. The responder can select display of lead vectors I. II. or III. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the FR3 continues to evaluate the patient's ECG. In addition, the FR3 alerts the responder to check the patient if the ECG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock. If the patient's rhythm or status changes, the responder can attend to the patient, as appropriate.
Product codes
MKJ, LDD, DPS, LIX
Device Description
These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philips SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithm for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self-tests performed each time the device is turned on, both models perform power on self-tests, runtime selftests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.
The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card an optional rechargeable Clinical Use Battery, an optional 3-Lead ECG Cable, an optional CPR Meter with Q-CPR Technology, and various carry cases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
Adults and children over 55 lbs (25 kg) or 8 years old. Also children under 55 lbs (25 kg) or 8 years old when used with the optional Infant/Child Key.
CPR Meter: suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg).
3-Lead ECG Cable: conscious or breathing patient, regardless of age.
Intended User / Care Setting
Trained responders qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.
The FR3 rechargeable battery is intended for use by organizations, such as EMS or fire departments that use the FR3 frequently.
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)
K111693, K013425, K014157, K122050, K051134
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Section 15 - 510(k) Summary
#K130684
1. Date Summary Prepared
2. Submitter's Name and Address
Philips Medical Systems 22100 Bothell Everett Highway Bothell, Washington 98021
OCT 1 8 2013
3. Contact Person
Nancy Burke Senior Regulatory Affairs Specialist Telephone: 425-908-2728 Facsimile: 425-487-7758
4. Device Name and Classification Panel Information
| Proprietary Name: | Philips HeartStart Model 861388 (text and graphics
only) and Model 861389 (ECG) AEDs |
|-------------------------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Automated External Defibrillator |
| Classification Name:
(Primary) | Automated External Defibrillator, 21 § 870.5310,
Product Code MKJ |
| Classification Name:
(Secondary) | Low energy DC Defibrillator, 21 § 870.5300, Product
Code LDD |
| Device Classification: | Class III pre-amendment (primary)
Class II (secondary) |
5. Predicate Devices
The legally marketed devices to which Philips Medical Systems claims equivalence for the Philips Heartstart Automated External Defibrillator (FR3) Models 861388 and 861389 with the optional 3-Lead ECG Cable, optional Rechargeable Clinical Use Battery and optional CPR Meter with Q-CPR Technology are:
Section 15, page 1 of 5
1
- Philips HeartStart models 861388 and 861389 ("FR3"), 510(k) #K111693 .
- Philips Heartstream FR2+ with ECG Cable, 510(k) #K013425 .
- Philips Heartstream FR2+ with Rechargeable Battery, 510(k) #K014157 o
- Laerdal Medical CPRmeter CPR Feedback Device, 510(k) #K122050 .
- HeartStart MRx monitor/defibrillator with O-CPR option, 510(k) #K051134 .
The design of the Philips Heartstart AED (FR3) Models 861388 and 861389 with the optional 3-Lead ECG Cable, optional Rechargeable Clinical Use Battery and optional CPR Meter with O-CPR Technology is substantially equivalent in safety and performance to the devices listed above.
6. Device Description
These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philips SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithm for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self-tests performed each time the device is turned on, both models perform power on self-tests, runtime selftests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.
The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card an optional rechargeable Clinical Use Battery, an optional 3-Lead ECG Cable, an optional CPR Meter with Q-CPR Technology, and various carry cases.
7. Intended Use
The models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The models 861388 and 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
- Unresponsiveness ●
- Absence of normal breathing .
2
If in doubt, apply the pads.
The models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 vears old when used with the optional Infant/Child Kev. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.
WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 lbs (25 kg) or 8 years old.
The models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.
CPR Meter with Q-CPR® Technology
The models 861388 and 861389 with the optional CPR meter and Q-CPR® Technology are designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lbs (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter.
WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lbs (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled.
When attached to the bare chest of a suspected victim of SCA and connected to a model 861388 or 861389 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth. release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 prompts the responder when it detects hyperventilation of the patient.
3-Lead ECG Cable
At the discretion of a responder trained in its use, the 3-Lead ECG Cable can be connected to the model 861389 to provide a non-diagnostic ECG display of the patient's heart rhythm. The responder can select to display lead vectors I, II, or III.
The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the model 861389 continues to evaluate the patient's ECG.
Section 15, page 3 of 5
3
8. Comparison of Technology Characteristics
The waveform used in the models 861389 and 861388 are unchanged in terms of specifications, nominal energy and peak current from those described in the previous submission, 510(k) #K111693. The algorithm used to determine shock recommendations and the SMART CPR algorithm that supports the CPR First function are also unchanged. Optional accessories offered with the models 861389 and 861388 are not changed from the previous submission.
Like the FR2+, the models 861388 and 861389 may be used with an optional Lithium Ion rechargeable battery. The batteries are similar in performance, use and safety characteristics. When used with a rechargeable battery, both the predicate device and the models 861388 and 861389 perform tests for battery status, provide indications of battery status, and provide low battery and replace battery prompts as needed.
Also like the FR2+, the model 861389 may be used with the optional 3-lead ECG cable to monitor ECG function; however, unlike the ECG Cable provided for the FR2+ which contains a battery, the ECG cable for the model 861389 is powered by the model 861389.
The CPR meter with Q-CPR technology is offered as an optional accessory with the models 861388 and 861389 for use during CPR and detects motion and force based on an embedded accelerometer and force sensor. The CPR meter is attached to and powered by the models 861388 and 861389, in the same manner as the Philips Compression Sensor offered with the Philips MRx Monitor/Defibrillator, while the CPRMeter™ by Laerdal is battery-powered. Feedback to the responder for depth, release, rate of compressions are similar between the CPR meter and the predicate devices. Ventilation information detected by attached defibrillator pads is provided by the models 861388 and 861389 and is a subset of that provided on the MRx, while the Laerdal stand-alone CPRMeter™ does not provide any ventilation feedback as it is not used with connected defibrillator pads.
9. Data Used in Determination of Substantial Equivalence
The models 861389 and 861388 employ many of the same technologies as those used in the predicate devices. Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates and do not raise any new issues of safety or effectiveness.
Section 15, page 4 of 5
4
10. Conclusion
The introduction of the models 861389 and 861388 with the new accessories and features are within the predicate device functionality and the differences do not raise new issues of safety or effectiveness.
Philips Medical Systems Traditional 510(k) PreMarket Notification 861388 and 861389 ·
.
Section 15, page 5 of 5
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a person with their arms outstretched.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2013
Philips Medical Systems Nancy Burke Senior Regulatory Affairs Specialist 22100 Bothell Everett Highway Bothell, Washington 98021
Re: K130684
Trade/Device Name: Philips HeartStart FR3 AED models 861388 (Text) and 861389 (ECG) Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LDD, DPS, LIX Dated: September 11, 2013 Received: September 12, 2013
Dear Ms. Burke:
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.
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
6
Page 2 - Ms. Nancy Burke
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen-P.Earis -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Section 12 - Indications for Use
510(k) Number (if known)
Device Name
Philips HeartStart FR3 Automated External Defibrillator (AED), Models 861388 and 861389
Indications for Use
The FR3 is intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The FR3 is used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:
- · Unresponsiveness
- · Absence of normal breathing
If in doubt, apply the pads.
The FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 Infant/Child Key. If the Infant/Child Kev is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.
The FR3 is intended for use by responders who have been trained in its operation and qualified by training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The FR3 can be configured under the guidance of a Medical Director to enable Advanced Use mode and alternative cardiopulmonary resuscitation (CPR) protocols, such as CPR while Armed, CPR First-User, and CPR First-Always.
WARNING: Performance of the SMART CPR AUTOI and AUTO2 settings for the CPR First feature has not been established in patients under 55 1b (25 kg) or 8 years old.
Philips Medical Systems Traditional 510(k) PreMarket Notification 861388 and 861389
8
CPR Meter with Q-CPR
The FR3 can be used with the optional CPR meter with Q-CPR® technology by Laerdal. The system is designed for application by a responder trained in its use. It serves as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old or 55 lb (25 kg). If the age or weight of the patient is in doubt, do not delay treatment. Perform CPR without using the CPR meter.
WARNING: The CPR meter is not intended for use on SCA victims under 8 years old or 55 lb (25 kg). If the Infant/Child Key is installed in the FR3, the CPR meter is disabled.
When attached to the bare chest of a suspected victim of SCA and connected to an FR3 used with compatible pads properly placed, the CPR meter provides real-time feedback on CPR in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, release, and rate of chest compressions. It also provides notification for lack of expected CPR activity and a stay-clear icon display during FR3 rhythm analysis and shock delivery. In addition, the FR3 alerts the responder when it detects hyperventilation (more than 12 ventilations per minute) of the patient during CPR.
3-Lead ECG Cable
In addition, at the discretion of a responder trained in its use, the optional FR3 3-Lead ECG Cable can be connected to the FR3 ECG model to provide a non-diagnostic ECG display of the heart rhythm of a patient who is responsive and breathing normally but at risk of cardiac distress. The system is intended for use on a conscious or breathing patient, regardless of age, for attended patient monitoring. The responder can select display of lead vectors I. II. or III. While connected to the 3-Lead Cable, the defibrillator's shock capability is disabled, but the FR3 continues to evaluate the patient's ECG. In addition, the FR3 alerts the responder to check the patient if the ECG indicates that the heart rate is less than 30 BPM or if the heart rhythm may benefit from a defibrillation shock. If the patient's rhythm or status changes, the responder can attend to the patient, as appropriate.
FR3 Rechargeable Battery
The FR3 rechargeable battery is intended for use by organizations, such as EMS or fire departments that use the FR3 frequently and want to decrease cost-per-use and reduce environmental waste. The rechargeable battery should only be used by organizations committed to providing the resources required to operate a battery maintenance program. Due to changes in the performance characteristics of rechargeable batteries over time, it is important for the battery maintenance program to monitor how many battery charge/discharge cycles the battery experiences, in order to determine when to retire it from service. The FR3 rechargeable battery is not recommended for infrequent-use
9
environments such as office buildings, airlines, or public access defibrillation (PAD) programs. It should not be used as the spare or backup battery; instead, the standard primary battery should be used due to its long shelf-life.
Over-The-Counter Use Prescription Use X 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)
Digitally signed by Owen P. Farls -5 Date: 2013.10.18 12:15:51
Philips Medical Systems Traditional 510(k) PreMarket Notification 861388 and 861389