FDA 510(k) Application Details - K200946

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K200946
Device Name	Thermometer, Electronic, Clinical
Applicant	TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Jacky Chou 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	04/08/2020
Decision Date	04/05/2022
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