FDA 510(k) Application Details - K211629

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K211629
Device Name	Thermometer, Electronic, Clinical
Applicant	Honsun (Nantong) Co., Ltd No.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong 226009 CN Other 510(k) Applications for this Company
Contact	Iris Du 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	05/27/2021
Decision Date	12/08/2021
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