SURESIGNS VS2+ -SURESIGNS VSI
FDA 510(k) clearance K112652 · decided 2011-10-11
Clearance details
- K-number
- K112652
- Device name
- SURESIGNS VS2+ -SURESIGNS VSI
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-09-12
- Decision date
- 2011-10-11
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- 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 SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments recall (Z-0268-2018) | Philips Electronics North America Corporation | 2017-12-20 |
| Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 Su recall (Z-0824-2013) | Philips Healthcare Inc. | 2013-02-14 |
| Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277 recall (Z-2303-2012) | Philips Healthcare Inc. | 2012-08-30 |
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 |