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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 K021112
Device Name INSPIRATION VENTILATOR SYSTEM
Applicant
EVENT MEDICAL LTD
800 GRAND AVE.
SUITE C3
CARLSBAD,  CA  92008
Applicant Contact MIKE GRIFFITHS
Correspondent
EVENT MEDICAL LTD
800 GRAND AVE.
SUITE C3
CARLSBAD,  CA  92008
Correspondent Contact MIKE GRIFFITHS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/05/2002
Decision Date 11/22/2002
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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