HEARTSTART MRX, MODELS M3535A OR M3536A
FDA 510(k) clearance K063375 · decided 2007-01-11
Clearance details
- K-number
- K063375
- Device name
- HEARTSTART MRX, MODELS M3535A OR M3536A
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2006-11-08
- Decision date
- 2007-01-11
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M35 recall (Z-1923-2019) | Philips North America, LLC | 2019-07-05 |
| HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536 recall (Z-0219-2016) | Philips Medical Systems, Inc. | 2015-11-05 |
| Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A recall (Z-0204-2016) | Philips Medical Systems, Inc. | 2015-11-03 |
| HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M353 recall (Z-0963-2015) | Philips Medical Systems, Inc. | 2015-01-13 |
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 |