KEOPS Balance Analyzer 3D

System, Image Processing, Radiological

S.M.A.I.O

The following data is part of a premarket notification filed by S.m.a.i.o with the FDA for Keops Balance Analyzer 3d.

Pre-market Notification Details

Device IDK213975
510k NumberK213975
Device Name:KEOPS Balance Analyzer 3D
ClassificationSystem, Image Processing, Radiological
Applicant S.M.A.I.O 2 Place Berthe Morisot Saint Priest,  FR 69800
ContactJean-charles Roussouly
CorrespondentRobert A Poggie
BioVera, Inc. 65 Promenade Saint Louis Notre Dame De Llle Perrot,  CA J7v7p2
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-20
Decision Date2022-05-06

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