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