FDA 510(k) Application Details - K171888

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K171888
Device Name	Thermometer, Electronic, Clinical
Applicant	Hetaida Technology Co., Ltd 4F, BaiShiDa High-Tech Park, XianDong Industrial Area, DaLingShan DongGuan 523820 CN Other 510(k) Applications for this Company
Contact	ZhenGuang Chen 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	06/26/2017
Decision Date	07/23/2018
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