CareEvent inclusive of the CareEvent Mobile Application accessory
FDA 510(k) clearance K161164 · decided 2016-06-24
Clearance details
- K-number
- K161164
- Device name
- CareEvent inclusive of the CareEvent Mobile Application accessory
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2016-04-25
- Decision date
- 2016-06-24
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- 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 |
|---|---|---|
| CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), So recall (Z-1387-2024) | Philips North America | 2024-03-27 |
| (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expa recall (Z-0731-2024) | Philips North America | 2024-01-13 |
| (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 recall (Z-0732-2024) | Philips North America | 2024-01-13 |
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| 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 |
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| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
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