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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
PO BOX 7550
3030 OHMEDA DR
MADISON,  WI  53707
Applicant Contact MONICA MORRISON
Correspondent
DATEX-OHMEDA
PO 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
Recalls CDRH Recalls
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