FDA 510(k) Application Details - K122267

Device Classification Name Warmer, Infant Radiant

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510(K) Number K122267
Device Name Warmer, Infant Radiant
Applicant OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
8880 GORMAN RD.
LAUREL, MD 20723 US
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Contact AGATA ANTHONY
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Regulation Number 880.5130

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Classification Product Code FMT
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Date Received 07/30/2012
Decision Date 10/02/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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