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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 K130178
Device Name INSPIRATION VENTILATOR SYSTEM 5I/7I
Applicant
Event Medical , Ltd.
971 Calle Amanecer
Suite 101
San Clemente,  CA  92673
Applicant Contact RICK WATERS
Correspondent
Event Medical , Ltd.
971 Calle Amanecer
Suite 101
San Clemente,  CA  92673
Correspondent Contact RICK WATERS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/25/2013
Decision Date 10/29/2013
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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