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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 K111116
Device Name ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
Applicant
Datex-Ohmeda
P.O. Box 7550
3030 Ohmeda Dr.
Madison,  WI  53707
Applicant Contact MONICA MORRISON
Correspondent
Datex-Ohmeda
P.O. Box 7550
3030 Ohmeda Dr.
Madison,  WI  53707
Correspondent Contact MONICA MORRISON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/21/2011
Decision Date 09/09/2011
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
Recalls CDRH Recalls
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