FDA 510(k) Application Details - K073366

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K073366
Device Name	Thermometer, Electronic, Clinical
Applicant	SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. 340 SHADY GROVE ROAD FLINTVILLE, TN 37335 US Other 510(k) Applications for this Company
Contact	CHARLES MACK 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	11/30/2007
Decision Date	02/08/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review