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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K152809
Device Name Giraffe Incubator Carestation CS1
Applicant
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
8880 GORMAN ROAD
LAUREL,  MD  20723
Applicant Contact KENNY BELLO
Correspondent
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
8880 GORMAN ROAD
LAUREL,  MD  20723
Correspondent Contact KENNY BELLO
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received09/28/2015
Decision Date 12/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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