EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)— 510(k) K012445

Name: FDA 510(k) clearance K012445
Creator: U.S. Food and Drug Administration
Published: 2001-08-24

Substantially Equivalent

Electro Medical Systems SA

FDA 510(k) clearance K012445 for EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA), Substantially Equivalent on 2001-08-24. Applicant: Electro Medical Systems SA. Device class: 2.

Clearance details

Applicant: Electro Medical Systems SA
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-01
Decision date: 2001-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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