K230893
- 510(k) number
- K230893
- Device name
- Swiss LthoClast Trilogy
- Applicant
- E.M.S Electro Medical Systems S.A CH
- Product code
- FEO — Lithotriptor, Ultrasonic
- Decision date
- 2023-10-23
- Date received
- 2023-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230893.pdf
Official FDA record: K230893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.