FDA 510(k) Application Details - K181997

Device Classification Name	Lithotriptor, Ultrasonic   More FDA Info for this Device
510(K) Number	K181997
Device Name	Lithotriptor, Ultrasonic
Applicant	EMS Electro Medical Systems SA Ch de la Vuarpilliere Nyon 1260 CH Other 510(k) Applications for this Company
Contact	Sonia Callegaro Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2018
Decision Date	08/30/2018
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