ENDURAVENT-5 VENTILATOR
FDA 510(k) clearance K092263 · decided 2010-01-21
Clearance details
- K-number
- K092263
- Device name
- ENDURAVENT-5 VENTILATOR
- Applicant
- Providence Global Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-28
- Decision date
- 2010-01-21
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.