FDA 510(k) Application Details - K031905

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K031905
Device Name	Thermometer, Electronic, Clinical
Applicant	ACTHERM, INC. 6TH F, NO 85 KUAN-MIN 6 ROAD JUBEI 302 HSINCHU 302 TW Other 510(k) Applications for this Company
Contact	RICHARD HSIEH 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	06/20/2003
Decision Date	07/07/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review