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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 K101804
Device Name GIRAFFE AND PANDA WARMERS
Applicant
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
8880 GORMAN RD.
LAUREL,  MD  20723
Applicant Contact AGATA SMIEJA
Correspondent
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
8880 GORMAN RD.
LAUREL,  MD  20723
Correspondent Contact AGATA SMIEJA
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/28/2010
Decision Date 07/21/2010
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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