FDA 510(k) Application Details - K232678

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K232678
Device Name	Thermometer, Electronic, Clinical
Applicant	Guangdong Genial Technology Co., Ltd. I-6-05-02, 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang Town, Huaiji Co Zhaoqing 526437 CN Other 510(k) Applications for this Company
Contact	Yu Jun 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	09/01/2023
Decision Date	01/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review