The following data is part of a premarket notification filed by Clearmind Biomedical with the FDA for Axonpen, Axonmonitor, Axonbox, Tablet.
| Device ID | K201308 |
| 510k Number | K201308 |
| Device Name: | Axonpen, Axonmonitor, Axonbox, Tablet |
| Classification | Endoscope, Neurological |
| Applicant | ClearMind Biomedical 5f, No 167, Fuxing N. Rd., Songshan Taipei, TW 105021 |
| Contact | Sheng-chi Lin |
| Correspondent | Craig Coombs Coombs Medical Device Consulting, Inc 1100 Pacific Marina, Suite 806 Alameda, CA 94501 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2020-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000321303 | K201308 | 000 |
| 10860000321317 | K201308 | 000 |