FDA 510(k) Application Details - K102227

Device Classification Name	Warmer, Infant Radiant   More FDA Info for this Device
510(K) Number	K102227
Device Name	Warmer, Infant Radiant
Applicant	ATOM MEDICAL CORPORATION 3-18-15 HONGO BUNKYO-KU, TOKYO 113-0033 JP Other 510(k) Applications for this Company
Contact	TSUYOSHI SUGINO 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	08/09/2010
Decision Date	01/21/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review