ROSA ONE Brain Application

Neurological Stereotaxic Instrument

Medtech S.A.S

The following data is part of a premarket notification filed by Medtech S.a.s with the FDA for Rosa One Brain Application.

Pre-market Notification Details

Device IDK214065
510k NumberK214065
Device Name:ROSA ONE Brain Application
ClassificationNeurological Stereotaxic Instrument
Applicant Medtech S.A.S 432 Rue Du Rajol Mauguio,  FR 34130
ContactPaul Hardy
CorrespondentPaul Hardy
Medtech S.A.S 432 Rue Du Rajol Mauguio,  FR 34130
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-27
Decision Date2022-05-04

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