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GIVEN DIAGNOSTIC IMAGING SYSTEM

DEN010002 Class II Post-NSE
Decision Date
2001-08-01
Sponsor / Applicant
Given Imaging , Ltd.

Technical Specification

510(k) Submission ID DEN010002
Product Code NEZ
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1300
Decision Date 2001-08-01
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

GIVEN DIAGNOSTIC IMAGING SYSTEM received FDA 510(k) clearance under submission number DEN010002, sponsored by Given Imaging , Ltd.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-08-01.

Classification & Regulation

This clearance is catalogued under FDA product code NEZ and 21 CFR 876.1300, within the Gastroenterology, Urology review panel as a Class II device.