HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
FDA 510(k) clearance K032821 · decided 2003-12-05
Clearance details
- K-number
- K032821
- Device name
- HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
- Applicant
- Hygia Health Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-05
- Decision date
- 2003-12-05
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- NPP
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.