SWISS LITHOBREAKER— 510(k) K123038

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K123038 for SWISS LITHOBREAKER, Substantially Equivalent on 2013-01-16. Applicant: E.M.S Electro Medical Systems S.A.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code FFK
Advisory panel: Gastroenterology, Urology
Date received: 2012-09-28
Decision date: 2013-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southbrough, MA, US

Download summary PDF View on FDA.gov ↗

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