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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K151570
Device Name Carestation 620/650/650C
Applicant
DATEX-OHMEDA, INC.
3030 OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact JAMES RASKOB
Correspondent
DATEX-OHMEDA, INC.
3030 OHMEDA DR.
P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact JAMES RASKOB
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/10/2015
Decision Date 01/21/2016
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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