GIVEN DIAGNOSTIC SYSTEM— 510(k) K052184

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K052184 for GIVEN DIAGNOSTIC SYSTEM, Substantially Equivalent on 2005-12-01. Applicant: Given Imaging , Ltd..

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code NSI
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-11
Decision date: 2005-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam (P.O.Box 258), IL

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