Evo SEEG System

Electrode, Depth

NeuroOne Medical Technologies Corp.

The following data is part of a premarket notification filed by Neuroone Medical Technologies Corp. with the FDA for Evo Seeg System.

Pre-market Notification Details

Device IDK211367
510k NumberK211367
Device Name:Evo SEEG System
ClassificationElectrode, Depth
Applicant NeuroOne Medical Technologies Corp. 7599 Anagram Drive Eden Prairie,  MN  55344
ContactJoseph Ostendorf
CorrespondentJoseph Ostendorf
Ostendorf Consulting, LLC 23879 Blue Spruce Road Sauk Centre,  MN  56378
Product CodeGZL  
CFR Regulation Number882.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2021-09-01

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