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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
Recalls CDRH Recalls
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