FDA 510(k) Application Details - K060461

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K060461
Device Name	Warmer, Infant Radiant
Applicant	ATOM MEDICAL INC IWAKATA BLDG 3RD FLOOR 3-18-15 HUNGO TOKOYO 1130033 JP Other 510(k) Applications for this Company
Contact	MARY STANIEWICZ 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	02/22/2006
Decision Date	04/28/2006
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