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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K112754
Device Name IVENT101
Applicant
Versamed Medical Systems , Ltd.
Hasharon Industrial Park
Ornat Bldg. P.O. Box 5011
Kadima,  IL 60920
Applicant Contact SHLOMI DELER
Correspondent
Versamed Medical Systems , Ltd.
Hasharon Industrial Park
Ornat Bldg. P.O. Box 5011
Kadima,  IL 60920
Correspondent Contact SHLOMI DELER
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received09/21/2011
Decision Date 06/15/2012
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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