FDA 510(k) Application Details - K043331

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K043331
Device Name	Thermometer, Electronic, Clinical
Applicant	HUBDIC CO., LTD 11820 RED HIBISCUS DR. BONITA SPRINGS, FL 34135 US Other 510(k) Applications for this Company
Contact	GUENTER GINSBERG 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	12/02/2004
Decision Date	03/04/2005
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