BIRD V.I.P. GOLD/STERLING
FDA 510(k) clearance K993449 · decided 1999-12-20
Clearance details
- K-number
- K993449
- Device name
- BIRD V.I.P. GOLD/STERLING
- Applicant
- Bird Products Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1999-10-12
- Decision date
- 1999-12-20
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Palm Spring, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653 recall (Z-0480-2007) | Viasys Respiratory Care, Inc. | 2007-01-11 |
| Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654 recall (Z-0481-2007) | Viasys Respiratory Care, Inc. | 2007-01-11 |