510(k) K173234

Swiss LithoClast Trilogy by E.M.S Electro Medical Systems S.A — Product Code FEO

K173234 is an FDA 510(k) premarket notification submitted by E.M.S Electro Medical Systems S.A for the device "Swiss LithoClast Trilogy". The FDA issued a decision of Substantially Equivalent on January 10, 2018. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. E.M.S Electro Medical Systems S.A has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2018
Date Received
October 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type