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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous, Ventilator, Home Use
510(k) Number K021981
Device Name IVENT 201 PORTABLE VENTILATOR
Applicant
Versamed , Ltd.
P.O.B. 5011, Ornat Bldg.
Hashron Industrial Park
Kadima,  IL 60920
Applicant Contact KEN RAICHMAN
Correspondent
Versamed , Ltd.
P.O.B. 5011, Ornat Bldg.
Hashron Industrial Park
Kadima,  IL 60920
Correspondent Contact KEN RAICHMAN
Regulation Number868.5895
Classification Product Code
NOU  
Subsequent Product Codes
CBK   DQA  
Date Received06/17/2002
Decision Date 08/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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