FDA 510(k) Application Details - K213011

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K213011
Device Name	Thermometer, Electronic, Clinical
Applicant	Bioland Technology Ltd No. A6B7 (Block G) ShangRong Industrial Zone, No. 5 Baolong Road Shenzhen 518116 CN Other 510(k) Applications for this Company
Contact	Wenjuan Xia 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	09/20/2021
Decision Date	04/05/2022
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