PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k) clearance K111693 · decided 2011-10-28
Clearance details
- K-number
- K111693
- Device name
- PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-06-16
- Decision date
- 2011-10-28
- Days to decision
- 134 days
- Clearance type
- Traditional
- 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 FR3 Automated External Defibrillator (AED), models 861388 and 861389. T recall (Z-1225-2014) | Philips Medical Systems North America Inc. | 2014-03-19 |
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 |