DeviceClearance

Product code OLT— Neurology

BRM2 BRAIN MONITOR

Classification name
Non-Normalizing Quantitative Electroencephalograph Software
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
56
First cleared
Most recent

FDA classification definition

“Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.”

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

Market context for product code OLT

FDA has cleared 56 devices under product code OLT between 1981 and 2026, filed by 46 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 OLT

Adverse events under product code OLT

product code OLT
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OLT

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