GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM— 510(k) DEN120023

Name: FDA 510(k) clearance DEN120023
Creator: U.S. Food and Drug Administration
Published: 2014-01-29

Unknown

Given Imaging , Ltd.

FDA 510(k) clearance DEN120023 for GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM, Unknown on 2014-01-29. Applicant: Given Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Given Imaging , Ltd.
Product code: Code PGD
Device class: Class 2
Regulation: 21 CFR 876.1330
Advisory panel: Gastroenterology, Urology
Date received: 2012-11-29
Decision date: 2014-01-29
Decision: Unknown
Clearance type: Direct
Location: Yoqneam, IL

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.