LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
FDA premarket approval P160012 · decided 2017-12-21
Approval details
- PMA number
- P160012
- Trade name
- LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Physio-Control, Inc.
- Date received
- 2016-04-27
- Decision date
- 2017-12-21
- Days to decision
- 603 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Approval for the LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger. The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patients in cardiac 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 devices are intended for use by personnel who have been trained in their operation. Users should have received tr
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 15 AC Power Adapter (41577-000333) (K253099) | Physio-Control, Inc. | 2025-10-14 |
| LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) (K240156) | Physio-Control, Inc. | 2024-04-30 |
| Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors (K182503) | Physio-Control, Inc. | 2019-06-03 |
| LIFEPAK 15 monitor/defibrillator (K142430) | Physio-Control, Inc. | 2014-12-19 |
| LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR (K130454) | Physio-Control, Inc. | 2013-08-21 |
| TRUECPR COACHING DEVICE (K123597) | Physio-Control, Inc. | 2013-04-17 |
| LIFEPAK 1000 DEFIBRILLATOR (K122600) | Physio-Control, Inc. | 2012-10-11 |
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K103567) | Physio-Control, Inc. | 2011-03-22 |