GIVEN DIAGNOSTIC SYSTEM

System, Imaging, Gastrointestinal, Wireless, Capsule

GIVEN IMAGING LTD.

The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Given Diagnostic System.

Pre-market Notification Details

Device IDK053639
510k NumberK053639
Device Name:GIVEN DIAGNOSTIC SYSTEM
ClassificationSystem, Imaging, Gastrointestinal, Wireless, Capsule
Applicant GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. BOX 258 Yoqneam,  IL 20692
ContactShoshana Friedman
CorrespondentShoshana Friedman
GIVEN IMAGING LTD. NEW INDUSTRIAL PARK P.O. BOX 258 Yoqneam,  IL 20692
Product CodeNEZ  
CFR Regulation Number876.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-30
Decision Date2006-05-08
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.