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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 K051550
Device Name INSPIRATION VENTILATOR SYSTEM
Applicant
EVENT MEDICAL LTD.
6A LIOSBAN BUSINESS PARK
TUAM ROAD
GALWAY,  IE
Applicant Contact ROBBIE WALSH
Correspondent
EVENT MEDICAL LTD.
6A LIOSBAN BUSINESS PARK
TUAM ROAD
GALWAY,  IE
Correspondent Contact ROBBIE WALSH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/13/2005
Decision Date 07/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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