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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 K093886
Device Name ENGSTROM CARESTATION, ENGSTROM PRO
Applicant
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
3030 OHMEDA DRIVE
MADISON,  WI  53718 -6794
Applicant Contact JIM RASKOB
Correspondent
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
3030 OHMEDA DRIVE
MADISON,  WI  53718 -6794
Correspondent Contact JIM RASKOB
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/18/2009
Decision Date 05/03/2010
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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