DeviceClearance

Product code NCG— Neurology

Ceribell Delirium Monitor System

Classification name
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device class
Class 2
Regulation
21 CFR 882.1440
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification definition

“Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."”

— U.S. Food and Drug Administration, device classification record for product code NCG under 21 CFR 882.1440, via openFDA

Market context for product code NCG

FDA has cleared 3 devices under product code NCG between 2013 and 2025, filed by 3 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 NCG

Recent clearances under product code NCG

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