Swiss LithoClast Trilogy— 510(k) K181364

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K181364 for Swiss LithoClast Trilogy, Substantially Equivalent on 2018-06-20. Applicant: E.M.S Electro Medical Systems S.A.

Clearance details

Applicant
E.M.S Electro Medical Systems S.A
Product code
Code FEO
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Nyon, CH
Download summary PDFView on FDA.gov ↗

Adverse events under product code FEO

product code FEO
Malfunction
910
Other
1
Total
911

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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