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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 K081845
Device Name IVENT101
Applicant
VERSAMED MEDICAL SYSTEMS, INC.
2 BLUE HILL PLAZA
BLDG. 2, 3RD FLOOR
PEARL RIVER,  NY  10965
Applicant Contact JERRY KORTEN
Correspondent
VERSAMED MEDICAL SYSTEMS, INC.
2 BLUE HILL PLAZA
BLDG. 2, 3RD FLOOR
PEARL RIVER,  NY  10965
Correspondent Contact JERRY KORTEN
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received06/30/2008
Decision Date 03/16/2009
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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