DeviceClearance

Product code OMA— Neurology

BRM3 BRAIN MONITOR

Classification name
Amplitude-Integrated Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
16
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code OMA under 21 CFR 882.1400, via openFDA

Market context for product code OMA

FDA has cleared 16 devices under product code OMA between 1979 and 2020, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OMA

Recent clearances under product code OMA

Data sourced from openFDA. This site is unofficial and independent of the FDA.