FDA 510(k) Application Details - K122912

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K122912
Device Name	Thermometer, Electronic, Clinical
Applicant	HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE WUCHANG, HANGZHOU, ZHEJIANG 310023 CN Other 510(k) Applications for this Company
Contact	AHNEO YANG 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	09/21/2012
Decision Date	11/07/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review