FDA 510(k) Application Details - K974195

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K974195
Device Name	Thermometer, Electronic, Clinical
Applicant	K-JUMP HEALTH CO., LTD. 581 CONFERENCE PLACE GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	ROBERT J ZAPPA 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	11/07/1997
Decision Date	02/04/1998
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