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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 K111473
Device Name UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
Applicant
Impact Instrumentation, Inc.
27 Fairfield Pl.
West Caldwell,  NJ  07006 -0508
Applicant Contact SUSAN MCNEVIN
Correspondent
Impact Instrumentation, Inc.
27 Fairfield Pl.
West Caldwell,  NJ  07006 -0508
Correspondent Contact SUSAN MCNEVIN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/27/2011
Decision Date 02/16/2012
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
Recalls CDRH Recalls
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