510(k) K091538

PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 by Wet Nose Technologies, LLC — Product Code CBP

K091538 is an FDA 510(k) premarket notification submitted by Wet Nose Technologies, LLC for the device "PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100". The FDA issued a decision of Substantially Equivalent on March 25, 2010. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Wet Nose Technologies, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2010
Date Received
May 26, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type