COMPLETE CONTROL System Gen2 is an AI-enabled medical device from Coapt, LLC, listed by FDA (510(k), K191083) with a decision date of 2019-05-24. Review panel: Neurology.
| FDA submission number | K191083 |
|---|---|
| Pathway | 510(k) |
| Company | Coapt, LLC |
| Review panel (specialty) | Neurology |
| FDA decision date | 2019-05-24 |
| Decision | Substantially Equivalent |
| Product code | GXY |
| Classification | Electrode, Cutaneous |
| Device class | 2 |
| Regulation number | 882.1320 |
| Review time (calendar days) | 30 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.