HeartStart FR3 Defibrillator
FDA premarket approval P160028/S004 · decided 2021-06-15
Approval details
- PMA number
- P160028
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartStart FR3 Defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Philips Medical Systems, Inc.
- Date received
- 2021-05-17
- Decision date
- 2021-06-15
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Approval for updating the safety alert from a Caution to a Warning in the instructions for use for the FRx and FR3 Infant/Child Keys.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PCR ELEVA 1.2 (K093355) | Philips Medical Systems, Inc. | 2010-01-08 |
| PINNACLE3 SMARTARC (K090808) | Philips Medical Systems, Inc. | 2009-04-03 |
| PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391) | Philips Medical Systems, Inc. | 2007-09-07 |
| PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783) | Philips Medical Systems, Inc. | 2007-04-27 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741) | Philips Medical Systems, Inc. | 2004-07-21 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN (K040955) | Philips Medical Systems, Inc. | 2004-05-12 |
| HEARTSTART MRX, MODEL M3535A (K040404) | Philips Medical Systems, Inc. | 2004-05-04 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II (K040357) | Philips Medical Systems, Inc. | 2004-03-03 |