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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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More FDA Info for this Product Code
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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