FDA 510(k), K192764, NeuroOne Cortical Electrode
FDA 510(k), K192764, NeuroOne Cortical Electrode
510(K) Number: K192764
Device Name: NeuroOne Cortical Electrode
Manufacturer: NeuroOne, Inc.
Device Classification Name: Electrode, Cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 09/30/2019
Decision Date: 11/26/2019
Regulation Medical Specialty: Neurology
Total pages: 815
Fully redacted pages: 704
Content pages: 111
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