LUNG DIFFUSION GAS MIXTURE
FDA 510(k) clearance K882817 · decided 1988-08-15
Clearance details
- K-number
- K882817
- Device name
- LUNG DIFFUSION GAS MIXTURE
- Applicant
- Swisco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-08
- Decision date
- 1988-08-15
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- BYK
- Device class
- 2
- Regulation number
- 868.5710
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lake Charles, LA, 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.
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|---|---|---|
| CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT (K941547) | Allied Healthcare Products, Inc. | 1995-03-01 |
| DISS FEMALE AIR ADAPTOR (K813235) | Timeter Instrument Corp. | 1981-12-08 |
Recalls involving this device
No recalls on record reference this clearance.