NeuralScan System

Full-montage Standard Electroencephalograph

Medeia, Inc.

The following data is part of a premarket notification filed by Medeia, Inc. with the FDA for Neuralscan System.

Pre-market Notification Details

Device IDK192753
510k NumberK192753
Device Name:NeuralScan System
ClassificationFull-montage Standard Electroencephalograph
Applicant Medeia, Inc. 7 W Figueroa Street, Suites 300 Santa Barbara,  CA  93101
ContactSlav Danev
CorrespondentDaniel Lehtonen
Compliance And Regulatory Services LLC 3771 Southbrook Dr Dayton,  OH  45430
Product CodeGWQ  
Subsequent Product CodeGWJ
Subsequent Product CodeOLT
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-03-17

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