BIRD 1000 PV PORTABLE VENTILATOR
FDA 510(k) clearance K925422 · decided 1993-05-13
Clearance details
- K-number
- K925422
- Device name
- BIRD 1000 PV PORTABLE VENTILATOR
- Applicant
- Bird Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-27
- Decision date
- 1993-05-13
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- CBC
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Palm Spring, 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 |
|---|---|---|
| AMBU SUCTION BOOSTER (K790035) | Narco Air-Shields | 1979-03-23 |
| BOTTLE, CONDENSATE (#1628) (K760082) | Inspiron Corp. | 1976-07-16 |
Recalls involving this device
No recalls on record reference this clearance.