SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
FDA 510(k) clearance K090483 · decided 2009-03-20
Clearance details
- K-number
- K090483
- Device name
- SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2009-02-25
- Decision date
- 2009-03-20
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- DPS
- Device class
- 2
- Regulation number
- 870.2340
- 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 VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564 recall (Z-2584-2011) | Philips Healthcare Inc. | 2011-06-17 |
| SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedsid recall (Z-0372-2010) | Philips Healthcare Inc. | 2009-11-23 |
| SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to inc recall (Z-0374-2010) | Philips Healthcare Inc. | 2009-11-23 |
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 |