Monarch ETNS System

NeuroSigma, Inc

The following data is part of a De Novo classification by Neurosigma, Inc with the FDA for Monarch Etns System.

Pre-market Notification Details

DeNovo IDDEN180041
Device Name:Monarch ETNS System
Applicant NeuroSigma, Inc 10960 Wilshire Boulevard suite 1910 Los Angeles,  CA  90024
ContactIan A. Cook
Product CodeQGL
DecisionGranted (DENG)
Review Advisory BoardNeurology
TypeDirect
Date Received2018-07-30
Decision Date2019-04-19

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