PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
FDA 510(k) clearance K050004 · decided 2005-02-25
Clearance details
- K-number
- K050004
- Device name
- PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-01-02
- Decision date
- 2005-02-25
- Days to decision
- 54 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Med recall (Z-0642-2013) | Philips Medical Systems North America Co. Phillips | 2013-01-04 |
| Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog numb recall (Z-0432-2011) | Philips Medical Systems | 2010-11-22 |
| Automated External Defibrillator (AED) of brand name "Philips HeartStart FRx" (Model numbe recall (Z-1915-2010) | Philips Medical Systems | 2010-06-28 |
| Philips Heartstart FRx automated external defibrillator (AED), Model 861304 recall (Z-1193-2010) | Philips Medical Systems | 2010-03-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |