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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K111191
Device Name AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
Applicant
Wet Nose Technologies, LLC
3750 2nd Ave.
Los Angeles,  CA  90018
Applicant Contact LIONEL NEWMAN
Correspondent
Wet Nose Technologies, LLC
3750 2nd Ave.
Los Angeles,  CA  90018
Correspondent Contact LIONEL NEWMAN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received04/28/2011
Decision Date 07/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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