DeviceClearance

Product code OMB— Neurology

Natus NeuroWorks

Classification name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
42
First cleared
Most recent

FDA classification definition

“Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user”

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

Market context for product code OMB

FDA has cleared 42 devices under product code OMB between 1987 and 2026, filed by 23 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 OMB

Recent clearances under product code OMB

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