PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
FDA 510(k) clearance K091538 · decided 2010-03-25
Clearance details
- K-number
- K091538
- Device name
- PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
- Applicant
- Wet Nose Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-05-26
- Decision date
- 2010-03-25
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.