BIRD TBIRD VELA VENTILATOR
FDA 510(k) clearance K032451 · decided 2004-03-17
Clearance details
- K-number
- K032451
- Device name
- BIRD TBIRD VELA VENTILATOR
- Applicant
- Bird Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-11
- Decision date
- 2004-03-17
- Days to decision
- 219 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Bird Products Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc. recall (Z-0638-2007) | Viasys Respiratory Care, Inc.dba Bird Products | 2007-03-20 |