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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
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