FDA 510(k), K201308, Axonpen, Axonmonitor, Axonbox, Tablet

510(K) Number: K201308
Device Name: Axonpen, Axonmonitor, Axonbox, Tablet
Manufacturer: ClearMind Biomedical
Device Classification Name: endoscope, neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 05/15/2020
Decision Date: 11/27/2020
Regulation Medical Specialty: Neurology

686 pages (2,122 of 2,808 original pages are fully redacted)