DISS FEMALE AIR ADAPTOR
FDA 510(k) clearance K813235 · decided 1981-12-08
Clearance details
- K-number
- K813235
- Device name
- DISS FEMALE AIR ADAPTOR
- Applicant
- Timeter Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-17
- Decision date
- 1981-12-08
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- BYK
- Device class
- 2
- Regulation number
- 868.5710
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT (K941547) | Allied Healthcare Products, Inc. | 1995-03-01 |
| LUNG DIFFUSION GAS MIXTURE (K882817) | Swisco, Inc. | 1988-08-15 |
Recalls involving this device
No recalls on record reference this clearance.