DeviceClearance

Product code OMC— Neurology

REMI Remote EEG Monitoring System

Classification name
Reduced- Montage Standard Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
29
First cleared
Most recent

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”

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

Market context for product code OMC

FDA has cleared 29 devices under product code OMC between 1978 and 2026, filed by 21 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

last 15 years

Top applicants under product code OMC

Recent clearances under product code OMC

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