SWISS LITHOBREAKER— 510(k) K123038
Substantially EquivalentE.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. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southbrough, MA, US
Recent devices under product code FFK
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