D²RS And D²RS 9090

Interventional Fluoroscopic X-ray System

Stephanix

The following data is part of a premarket notification filed by Stephanix with the FDA for D²rs And D²rs 9090.

Pre-market Notification Details

Device IDK213479
510k NumberK213479
Device Name:D²RS And D²RS 9090
ClassificationInterventional Fluoroscopic X-ray System
Applicant Stephanix 10, Rue Jean Moulin Z.I Du Bayon La Ricamarie,  FR 42150
ContactSandie Perret
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeOWB  
Subsequent Product CodeIZI
Subsequent Product CodeJAA
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-29
Decision Date2021-12-23

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