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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 K152814
Device Name Giraffe OmniBed Carestation CS1
Applicant
Ohmeda Medical, a Division of Datex-Ohmeda,Inc. A GE Company
8880 Gorman Rooad
Laurel,  MD  20723
Applicant Contact Kenny M Bello
Correspondent
Ohmeda Medical, a Division of Datex-Ohmeda,Inc. A GE Company
8880 Gorman Rooad
Laurel,  MD  20723
Correspondent Contact Kenny M Bello
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
FMT  
Date Received09/28/2015
Decision Date 03/17/2016
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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