Surgivisio System

Interventional Fluoroscopic X-ray System

Surgivisio

The following data is part of a premarket notification filed by Surgivisio with the FDA for Surgivisio System.

Pre-market Notification Details

Device IDK202547
510k NumberK202547
Device Name:Surgivisio System
ClassificationInterventional Fluoroscopic X-ray System
Applicant Surgivisio Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gières,  FR 38610
ContactVincent Lere
CorrespondentElodie Bouillet
Surgivisio Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gières,  FR 38610
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-02
Decision Date2021-03-26

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