HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
FDA premarket approval P160029/S012 · decided 2021-06-15
Approval details
- PMA number
- P160029
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartStart OnSite Defibrillator and HeartStart Home Defibrillator
- Generic name
- Over-the-counter automated external defibrillator
- Applicant
- Philips Medical Systems, Inc.
- Date received
- 2021-05-21
- Decision date
- 2021-06-15
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NSA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- New battery end of line test equipment for the HS1 and FRx Primary Battery, and the FRx Aviation Battery at the contract manufacturer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |