FDA 510(k) Application Details - K072635

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K072635
Device Name	Thermometer, Electronic, Clinical
Applicant	NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. SUITE 8D, NO. 19 LANE 999 SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	09/18/2007
Decision Date	01/17/2008
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