FDA 510(k) Application Details - K243032

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K243032
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Room 603, Building C2, Innovation Building, No. 182 Science Avenue, Huangpu District Guangzhou 510000 CN Other 510(k) Applications for this Company
Contact	Zhengzhou Li Other 510(k) Applications for this Contact
Regulation Number	876.4480   More FDA Info for this Regulation Number
Classification Product Code	FFK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	03/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review