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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 K052554
Device Name MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
Applicant
Versamed Medical Systems, Inc.
2 Blue Hill Plz.
Bldg. 2, 3rd Floor
Pearl River,  NY  10965
Applicant Contact JERRY KORTEN
Correspondent
Versamed Medical Systems, Inc.
2 Blue Hill Plz.
Bldg. 2, 3rd Floor
Pearl River,  NY  10965
Correspondent Contact JERRY KORTEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/16/2005
Decision Date 09/23/2005
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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