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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cortical
510(k) Number K192764
Device Name NeuroOne Cortical Electrode
NeuroOne, Inc.
10901 Red Circle Dr., Suite 150
minnetonka,  MN  55343
Applicant Contact debra kridner
Debra J Kridner
10901 Red Circle Dr., Suite 150
minnetonka,  MN  55343
Correspondent Contact debra kridner
Regulation Number882.1310
Classification Product Code
Date Received09/30/2019
Decision Date 11/26/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No