CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
FDA 510(k) clearance K941547 · decided 1995-03-01
Clearance details
- K-number
- K941547
- Device name
- CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
- Applicant
- Allied Healthcare Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-30
- Decision date
- 1995-03-01
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- BYK
- Device class
- 2
- Regulation number
- 868.5710
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Saint Louis, MO, 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 |
|---|---|---|
| LUNG DIFFUSION GAS MIXTURE (K882817) | Swisco, Inc. | 1988-08-15 |
| DISS FEMALE AIR ADAPTOR (K813235) | Timeter Instrument Corp. | 1981-12-08 |
Recalls involving this device
No recalls on record reference this clearance.