FDA 510(k) Application Details - K191124

Device Classification Name	Lithotriptor, Electro-Hydraulic   More FDA Info for this Device
510(K) Number	K191124
Device Name	Lithotriptor, Electro-Hydraulic
Applicant	EMS Electro Medical Systems SA Ch. De la Vuarpilliere 31 Nyon 1260 CH Other 510(k) Applications for this Company
Contact	Timothee Deblock 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	04/29/2019
Decision Date	05/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review