FDA 510(k) Application Details - K222385

Device Classification Name	System, Delivery, Allergen And Vaccine   More FDA Info for this Device
510(K) Number	K222385
Device Name	System, Delivery, Allergen And Vaccine
Applicant	Anhui Tiankang Medical Technology Co., Ltd. No.228,Weiyi Road, Economic Development Zone Tianchang 239300 CN Other 510(k) Applications for this Company
Contact	Zhang Yong Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2022
Decision Date	12/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review