GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE— 510(k) K041149

Name: FDA 510(k) clearance K041149
Creator: U.S. Food and Drug Administration
Published: 2004-10-25

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K041149 for GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE, Substantially Equivalent on 2004-10-25. 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: 2004-05-03
Decision date: 2004-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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