ULTRACHECK CURVE BLOOD PRESSURE CUFFS
FDA 510(k) clearance K122365 · decided 2013-06-04
Clearance details
- K-number
- K122365
- Device name
- ULTRACHECK CURVE BLOOD PRESSURE CUFFS
- Applicant
- Statcorp Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-08-06
- Decision date
- 2013-06-04
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- OED
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Jacksonville, FL, 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 |
|---|---|---|
| ANTIMICROBIAL AND SINGLE-PATIENT CUFFS (K071885) | Philips Medical Systems | 2007-12-20 |
Recalls involving this device
No recalls on record reference this clearance.