OMA

Amplitude-Integrated Electroencephalograph

Product code: OMA
Device name: Amplitude-Integrated 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): 16

FDA classification definition

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

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

Official FDA classification page: OMA

Classification and pathway per current FDA publications. Data from openFDA (CC0).