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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K132903
Device Name DRE VENTURA
Applicant
DRE MEDICAL, INC.
1800 WILLIAMSON CT.
LOUISVILLE,  KY  40026
Applicant Contact PAUL DRYDEN
Correspondent
DRE MEDICAL, INC.
1800 WILLIAMSON CT.
LOUISVILLE,  KY  40026
Correspondent Contact PAUL DRYDEN
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/16/2013
Decision Date 07/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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