Waratah Digital EEG and Sleep Acquisition Devices with, or without, Pulse Oximetry,cardinal Digital EEG and Sleep Acquis

K990522 is the FDA 510(k) clearance record for WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS, a class II device, cleared for Lamont Medical, Inc. on 1999-05-19 under FDA product code OLV (Standard Polysomnograph With Electroencephalograph). FDA's definition for product code OLV reads: "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...". FDA records list 2 510(k) clearances for Lamont Medical, Inc., from 1999-05-19 to 2004-09-30. As of 2026-09-10, FDA records show no recalls naming K990522.