BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
FDA 510(k) clearance K971892 · decided 1998-08-05
Clearance details
- K-number
- K971892
- Device name
- BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651
- Applicant
- Biomedical Horizons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-22
- Decision date
- 1998-08-05
- Days to decision
- 440 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Jackson, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.