FDA 510(k) Application Details - K112289

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K112289
Device Name	Thermometer, Electronic, Clinical
Applicant	KANG ZE INDUSTRIAL CO. LIMITED RM 1706 YUESHA BLDG NO 128 SONGLE RD SONGJIANG AREA, SHANGHAI 201600 CN Other 510(k) Applications for this Company
Contact	DORIS DONG 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	08/09/2011
Decision Date	12/16/2011
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