POM

Computerized Cognitive Assessment Aid For Concussion

Product code

POM

Device name

Computerized Cognitive Assessment Aid For Concussion

Device class

Class 2

21 CFR

21 CFR 882.1471

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification definition

For use as an assessment aid in the management of concussion.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-02-15.

2 summaries are archived here for direct download.