VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR— 510(k) K092033

Name: FDA 510(k) clearance K092033
Creator: U.S. Food and Drug Administration
Published: 2010-04-30

Substantially Equivalent

Elmed USA

FDA 510(k) clearance K092033 for VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR, Substantially Equivalent on 2010-04-30. Applicant: Elmed USA. Device class: 2.

Clearance details

Applicant: Elmed USA
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 2009-07-06
Decision date: 2010-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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