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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K110631
Device Name VENNER TRACHEAL SEAL MONITOR
Applicant
Venner Medical (Singapore) Pte, Ltd.
7 Trl. House Ct.
Rockville,  MD  20850
Applicant Contact HCHRISTINE BRAUER, PH.D.
Correspondent
Venner Medical (Singapore) Pte, Ltd.
7 Trl. House Ct.
Rockville,  MD  20850
Correspondent Contact HCHRISTINE BRAUER, PH.D.
Regulation Number868.5750
Classification Product Code
BSK  
Date Received03/04/2011
Decision Date 07/28/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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