Swiss LithoClast Trilogy— 510(k) K191124

Name: FDA 510(k) clearance K191124
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K191124 for Swiss LithoClast Trilogy, Substantially Equivalent on 2019-05-29. Applicant: E.M.S Electro Medical Systems S.A. Device class: 2.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-29
Decision date: 2019-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Nyon, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.