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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 K030341
Device Name MODIFICATION TO 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 Received02/03/2003
Decision Date 01/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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