FDA 510(k) Application Details - K232957

Device Classification Name	Media,Coupling,Ultrasound   More FDA Info for this Device
510(K) Number	K232957
Device Name	Media,Coupling,Ultrasound
Applicant	Jianerkang Medical Co., Ltd NO.1,Jianerkang Road, Zhixi Town Industrial Zone jintan District Changzhou 213251 CN Other 510(k) Applications for this Company
Contact	Zhang Zhigang Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	MUI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2023
Decision Date	12/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review