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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 K072590
Device Name INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
Applicant
Event Medical, Inc.
81 Columbia, Suite 101
Aliso Viejo,  CA  92656
Applicant Contact ROBERT LUNDBERG
Correspondent
Event Medical, Inc.
81 Columbia, Suite 101
Aliso Viejo,  CA  92656
Correspondent Contact ROBERT LUNDBERG
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/14/2007
Decision Date 01/04/2008
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
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