GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE— 510(k) K071153

Name: FDA 510(k) clearance K071153
Creator: U.S. Food and Drug Administration
Published: 2007-06-11

Substantially Equivalent

Given Imaging , Ltd.

FDA 510(k) clearance K071153 for GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE, Substantially Equivalent on 2007-06-11. 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: 2007-04-25
Decision date: 2007-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Calgary, Alberta, CA

Download summary PDF View on FDA.gov ↗

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