Device type

Standard Polysomnograph With Electroencephalograph

Product code OLV · Class II · 21 CFR 882.1400 · Neurology

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.

FDA classification database