SURGIVISIO Device

Interventional Fluoroscopic X-ray System

Ecential Robotics

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

Pre-market Notification Details

Device IDK220946
510k NumberK220946
Device Name:SURGIVISIO Device
ClassificationInterventional Fluoroscopic X-ray System
Applicant Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres,  FR 38610
ContactMathilde Saulpic
CorrespondentMathilde Saulpic
Ecential Robotics Zone Mayencin II, Parc Equation - Bâtiment 1, 2 Avenue De Vignate Gieres,  FR 38610
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-01
Decision Date2022-04-15

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