System, X-ray, Mobile


The following data is part of a premarket notification filed by Stephanix with the FDA for Movix Dreamy.

Pre-market Notification Details

Device IDK212515
510k NumberK212515
Device Name:MOVIX DReamy
ClassificationSystem, X-ray, Mobile
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 CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-10
Decision Date2021-11-03

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