LIFEPAK® CR2 Defibrillator
FDA premarket approval P170018/S004 · decided 2019-10-23
Approval details
- PMA number
- P170018
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFEPAK® CR2 Defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Physio-Control, Inc.
- Date received
- 2019-09-11
- Decision date
- 2019-10-23
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Approval for a labeling change to support a different configuration of the LIFEPAK CR2 defibrillator.
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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 |