HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40
FDA 510(k) clearance K012654 · decided 2002-04-12
Clearance details
- K-number
- K012654
- Device name
- HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40
- Applicant
- Hygia Health Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2002-04-12
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
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| PnueAira (PNCU-01) (K251086) | Biotab, LLC | 2025-08-18 |
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Recalls involving this device
No recalls on record reference this clearance.