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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name warmer, infant radiant
510(k) Number K122267
Device Name GIRAFFE AND PANDA WARMERS
Original Applicant
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
8880 gorman rd.
laurel,  MD  20723
Original Contact agata anthony
Regulation Number880.5130
Classification Product Code
FMT  
Date Received07/30/2012
Decision Date 10/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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