MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM— 510(k) K060805

Name: FDA 510(k) clearance K060805
Creator: U.S. Food and Drug Administration
Published: 2006-05-24

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K060805 for MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM, Substantially Equivalent on 2006-05-24. Applicant: Given Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NSI
Device class: Class 2
Regulation: 21 CFR 876.1300
Advisory panel: Gastroenterology, Urology
Date received: 2006-03-24
Decision date: 2006-05-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam (P.O.Box 258), IL

Download summary PDF View on FDA.gov ↗

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