BICORE VARIFLEX(R) FLOW TRANSDUCER
FDA 510(k) clearance K896718 · decided 1990-02-22
Clearance details
- K-number
- K896718
- Device name
- BICORE VARIFLEX(R) FLOW TRANSDUCER
- Applicant
- Bicore Monitoring Systems
- Decision
- Substantially Equivalent
- Date received
- 1989-11-29
- Decision date
- 1990-02-22
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- BYR
- Device class
- 1
- Regulation number
- 868.2875
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, 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 |
|---|---|---|
| MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS (K801880) | Medical Measurements, Inc. | 1980-08-14 |
| DRAGER ORM (K790334) | Draeger Medical, Inc. | 1979-03-07 |
Recalls involving this device
No recalls on record reference this clearance.