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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 K103318
Device Name UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
Applicant
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
P.O. BOX 508
WEST CALDWELL,  NJ  07006 -0508
Applicant Contact SUSAN MCNEVIN
Correspondent
IMPACT INSTRUMENTATION, INC.
27 FAIRFIELD PL.
P.O. BOX 508
WEST CALDWELL,  NJ  07006 -0508
Correspondent Contact SUSAN MCNEVIN
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received11/12/2010
Decision Date 04/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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