VELA VENTILATOR
FDA 510(k) clearance K093094 · decided 2010-05-11
Clearance details
- K-number
- K093094
- Device name
- VELA VENTILATOR
- Applicant
- Cardinal Health 207, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-01
- Decision date
- 2010-05-11
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.