OLV

Standard Polysomnograph With Electroencephalograph

Product code

OLV

Device name

Standard Polysomnograph With Electroencephalograph

Device class

Class 2

21 CFR

21 CFR 882.1400

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

65

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-08-25.