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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 K041524
Device Name GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
Applicant
DATEX-OHMEDA, INC.
PO BOX 7550
MADISON,  WI  53707
Applicant Contact DAN KOSEDNAR
Correspondent
DATEX-OHMEDA, INC.
PO BOX 7550
MADISON,  WI  53707
Correspondent Contact DAN KOSEDNAR
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/08/2004
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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