FDA 510(k) Application Details - K100226

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K100226
Device Name	Thermometer, Electronic, Clinical
Applicant	RIO FLEXON TECHNOLOGY CO., LTD. 15F,868-2, JHONG JHENG RD., JHONGHE CITY TAIPEI COUNTY 235 TW Other 510(k) Applications for this Company
Contact	CHI-HUNG LIAO Other 510(k) Applications for this Contact
Regulation Number	880.2910   More FDA Info for this Regulation Number
Classification Product Code	FLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2010
Decision Date	03/18/2010
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