FDA 510(k) Application Details - K220084

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K220084
Device Name	Thermometer, Electronic, Clinical
Applicant	Qingdao Yasee Medical Device Co., Ltd. No.9 Xiuyuan Road, High-tech Industrial Development Zone Qingdao 266112 CN Other 510(k) Applications for this Company
Contact	Shaoju Tian 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	01/10/2022
Decision Date	09/12/2022
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	Y
Expedited Review