FDA 510(k) Application Details - K964286

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K964286
Device Name	Thermometer, Electronic, Clinical
Applicant	ZOMED INTL. 967 NORTH SHORELINE BLVD. MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	THOMAS C WEHMAN, PH.D. 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	10/28/1996
Decision Date	11/19/1996
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