FDA 510(k) Application Details - K210565

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K210565
Device Name	Thermometer, Electronic, Clinical
Applicant	Alicn Medical Shenzhen,Inc Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng Life Science Park, Kengzi Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Fang Meisong 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	02/25/2021
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	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review