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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K201308
Device Name Axonpen, Axonmonitor, Axonbox, Tablet
Applicant
ClearMind Biomedical
5f, No 167, Fuxing N. Rd., Songshan
Taipei,  TW 105021
Applicant Contact Sheng-Chi Lin
Correspondent
Coombs Medical Device Consulting, Inc
1100 Pacific Marina, Suite 806
Alameda,  CA  94501
Correspondent Contact Craig Coombs
Regulation Number882.1480
Classification Product Code
GWG  
Date Received05/15/2020
Decision Date 11/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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