FDA 510(k) Application Details - K212346

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K212346
Device Name	Thermometer, Electronic, Clinical
Applicant	Shenzhen Pango Medical Electronics Co., Ltd. No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village Henggang Town, Longgang District Shenzhen 518115 CN Other 510(k) Applications for this Company
Contact	Youjian Xie 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	07/28/2021
Decision Date	05/05/2022
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