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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 K123309
Device Name GIRAFFE AND PANDA WARMERS
Applicant
Ohmeda Medical
8880 Gorman Rd.
Laurel,  MD  20723
Applicant Contact AGATA ANTHONY
Correspondent
Ohmeda Medical
8880 Gorman Rd.
Laurel,  MD  20723
Correspondent Contact AGATA ANTHONY
Regulation Number880.5130
Classification Product Code
FMT  
Date Received10/24/2012
Decision Date 02/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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