FDA 510(k) Application Details - K180714

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K180714
Device Name	Thermometer, Electronic, Clinical
Applicant	K-jump Health Co., Ltd. No. 56, Wu Kung 5th Rd. New Taipei Industrial Park New Taipei City 24890 TW Other 510(k) Applications for this Company
Contact	JM Lin 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	03/19/2018
Decision Date	09/24/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review