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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 K062710
Device Name GE DATEX-OHMEDA ENGSTROM CARESTATION
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 Received09/11/2006
Decision Date 12/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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