FDA 510(k) Application Details - K212945

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K212945
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen Envisen Industry Co., Ltd Block 1, Room 201, 301, 401, 40 Jianlong Street Baoan Community, Yuanshan Town, Longgang Dist Shenzhen 518115 CN Other 510(k) Applications for this Company
Contact	Ailsa Huang 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	09/15/2021
Decision Date	03/01/2022
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