DeviceClearance

Product code OLV— Neurology

Noxturnal Web

Classification name
Standard Polysomnograph With Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
65
First cleared
Most recent

FDA classification definition

“Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.”

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

Market context for product code OLV

FDA has cleared 65 devices under product code OLV between 1986 and 2026, filed by 37 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 OLV

Recent clearances under product code OLV

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