ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
FDA 510(k) clearance K071885 · decided 2007-12-20
Clearance details
- K-number
- K071885
- Device name
- ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2007-07-09
- Decision date
- 2007-12-20
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- OED
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| ULTRACHECK CURVE BLOOD PRESSURE CUFFS (K122365) | Statcorp Medical | 2013-06-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
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| 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 |