PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
FDA 510(k) clearance K031422 · decided 2003-07-03
Clearance details
- K-number
- K031422
- Device name
- PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-05-06
- Decision date
- 2003-07-03
- Days to decision
- 58 days
- Clearance type
- Abbreviated
- Product code
- DPS
- Device class
- 2
- Regulation number
- 870.2340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator (861304) (P180028/S019) | Philips Medical Systems | 2026-05-21 |
| HeartStart FRx Defibrillator (P180028/S018) | Philips Medical Systems | 2026-02-02 |
| 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 |