FDA 510(k) Application Details - K013876

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K013876
Device Name	Thermometer, Electronic, Clinical
Applicant	JAWON MEDICAL CO., LTD. JEONG-JU B/D 7F,1451-38, SEOCHO-DONG SEOUL 137-070 KR Other 510(k) Applications for this Company
Contact	WON-HEE PARK 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	11/23/2001
Decision Date	03/04/2002
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	Y
Expedited Review