Swiss LithoClast Trilogy

Lithotriptor, Ultrasonic

E.M.S Electro Medical Systems SA

The following data is part of a premarket notification filed by E.m.s Electro Medical Systems Sa with the FDA for Swiss Lithoclast Trilogy.

Pre-market Notification Details

• Device ID: K173234
• 510k Number: K173234
• Device Name: Swiss LithoClast Trilogy
• Classification: Lithotriptor, Ultrasonic
• Applicant: E.M.S Electro Medical Systems SA Ch De La Vuarpilliere, 31 Nyon, CH 1260
• Contact: Sonia Callegaro
• Correspondent: Sheila Hemeon-heyer; Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002
• Product Code: FEO
• CFR Regulation Number: 876.4480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-05
• Decision Date: 2018-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613353221836	K173234	000
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07613353164027	K173234	000