LIFEPAK® CR2 Defibrillator
FDA premarket approval P170018 · Automated external defibrillators (non-wearable)
Approval
- Applicant
- Physio-Control, Inc.
- Received
- May 31, 2017
- Decision date
- December 21, 2018 (APPR)
- Supplements
- 25, latest July 30, 2026
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
Approval order statement
Approval for the LIFEPAK® CR2 Defibrillator. The device is indicated for use on patients 1 year of age and older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement).The cprCOACH Feedback Technology in the LIFEPAK® CR2 Defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age and older.The LIFEPAK® CR2 Defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support or a physician-authorized emergency medical response training program.The LIFEPAK® CR2 Defibrillator is indicated to be used with the QUIK-STEP Pacing/ECG Defibrillation Electrodes and the LIFEPAK CR2 Lithium Battery.