FDA 510(k) Application Details - K083185

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K083185
Device Name	Thermometer, Electronic, Clinical
Applicant	CADI SCIENTIFIC PTE.LTD S65 W35739 PIPER ROAD EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN H GORSKI 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	10/29/2008
Decision Date	03/11/2009
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