FDA 510(k) Application Details - K963049

Device Classification Name	Thermometer, Clinical Color Change   More FDA Info for this Device
510(K) Number	K963049
Device Name	Thermometer, Clinical Color Change
Applicant	STERI-AID, INC. 1057 STEELES AVE WEST,P.O. BOX 81614,CONCOURSE POSTAL OUTLET NORTH YORK,ONTARIO M2R 3X1 CA Other 510(k) Applications for this Company
Contact	MARTIN ROMAIN Other 510(k) Applications for this Contact
Regulation Number	880.2900   More FDA Info for this Regulation Number
Classification Product Code	FQZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/1996
Decision Date	11/12/1996
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	N
Expedited Review