LED PHOTIC System

Stimulator, Photic, Evoked Response

Micromed S.p.A.

The following data is part of a premarket notification filed by Micromed S.p.a. with the FDA for Led Photic System.

Pre-market Notification Details

Device IDK211974
510k NumberK211974
Device Name:LED PHOTIC System
ClassificationStimulator, Photic, Evoked Response
Applicant Micromed S.p.A. Via Giotto 2 Mogliano Veneto,  IT 31021
ContactNicola Rizzo
CorrespondentMarina Ruotolo
Micromed S.p.A. Via Giotto 2 Mogliano Veneto,  IT 31021
Product CodeGWE  
CFR Regulation Number882.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-25
Decision Date2021-09-23

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