SureSigns VS3; SureSigns VS4
FDA 510(k) clearance K163649 · decided 2017-03-31
Clearance details
- K-number
- K163649
- Device name
- SureSigns VS3; SureSigns VS4
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2016-12-23
- Decision date
- 2017-03-31
- Days to decision
- 98 days
- Clearance type
- Special
- Product code
- DSJ
- Device class
- 2
- Regulation number
- 870.1100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EarlyVue VS30 (K190624) | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 |
| SureSigns VS3, SureSigns VS4 (K151761) | Phillips Medical Systems | 2015-09-29 |
| SURESIGNS VS3, SURESIGNS VS4 (K133961) | Philips Medical Systems | 2014-06-26 |
| SAMS 8000 CARDIOPLEGIA MONITOR (K960916) | 3M Health Care, Sarns | 1996-06-04 |
| KELLER VITAL SIGNS MONITOR - KMS-890 (K910262) | Keller Medical Specialties Products, Inc. | 1991-04-01 |
Recalls involving this device
No recalls on record reference this clearance.
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 |