FDA 510(k) Application Details - K213772

Device Classification Name	Lithotriptor, Extracorporeal Shock-Wave,Urological   More FDA Info for this Device
510(K) Number	K213772
Device Name	Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant	Lite-Med Inc. 9th Floor, 49 Dongxing Road, Xinyi District Taipei 11070 TW Other 510(k) Applications for this Company
Contact	Walt Hsu Other 510(k) Applications for this Contact
Regulation Number	876.5990   More FDA Info for this Regulation Number
Classification Product Code	LNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2021
Decision Date	01/19/2023
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