FDA 510(k) Application Details - K180387

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K180387
Device Name	Thermometer, Electronic, Clinical
Applicant	HeTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Foshan City 523820 CN Other 510(k) Applications for this Company
Contact	Tom 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	02/12/2018
Decision Date	01/10/2019
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