OMC

Reduced- Montage Standard Electroencephalograph

Product code

OMC

Device name

Reduced- Montage Standard Electroencephalograph

Device class

Class 2

21 CFR

21 CFR 882.1400

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

7

Summaries archived here

7 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

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

510(k) clearances, last 3 years (7)

Last three years. Most recent: 2026-06-30.

7 summaries are archived here for direct download.