Identity
- Trade Name
- LIFEPAK® CR2 Defibrillator FDA PMA
- Generic Name
- Automated external defibrillators (non-wearable) FDA PMA
Identifiers
- PMA Number
- P170018 FDA PMA
- FDA Product Code
- MKJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5310 FDA PMA
- Regulation Number
- 870.5310 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The LIFEPAK CR2 Defibrillator is an automated external defibrillator (non-wearable) indicated for use on patients 1 year of age and older in cardiopulmonary arrest. It provides defibrillation therapy and includes cprCOACH Feedback Technology to guide CPR in accordance with AHA Guidelines.
It is intended for use by trained personnel with basic life support/AED, advanced life support, or physician-authorized emergency medical response training. The device is used with QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery, and has received FDA PMA approval (P170018).
Frequently asked questions
What is the minimum age for use of the LIFEPAK CR2 Defibrillator?
The LIFEPAK CR2 Defibrillator is indicated for use on patients 1 year of age and older in cardiopulmonary arrest, as stated in the approval documentation.
What training is required to operate the LIFEPAK CR2 Defibrillator?
Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program to operate the device safely and effectively.
What accessories are required for the LIFEPAK CR2 Defibrillator to function?
The device is intended to be used with the QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery, as specified in the approval documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P170018 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA PMA P170018 24 fields · synced Sep 18, 2026