UroNav (Version 2.0)

System, Image Processing, Radiological

INVIVO CORPORATION

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Uronav (version 2.0).

Pre-market Notification Details

Device IDK153073
510k NumberK153073
Device Name:UroNav (Version 2.0)
ClassificationSystem, Image Processing, Radiological
Applicant INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville,  FL  32608
ContactKenneth Revennaugh
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-10-22
Decision Date2015-11-16
Summary:summary

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