FDA 510(k) Application Details - K101804

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K101804
Device Name	Warmer, Infant Radiant
Applicant	OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., 8880 GORMAN RD. LAUREL, MD 20723 US Other 510(k) Applications for this Company
Contact	AGATA SMIEJA Other 510(k) Applications for this Contact
Regulation Number	880.5130   More FDA Info for this Regulation Number
Classification Product Code	FMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2010
Decision Date	07/21/2010
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