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Waratah Digital EEG and Sleep Acquisition Devices

by Lamont Medical, Inc.

510(k) K990522

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990522 Date19 May 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Waratah Digital EEG and Sleep Acquisition Devices with, or Without, Pulse Oximetry, Cardinal Digital EEG and Sleep Acquis
510(k) Number
FDA Product Code
OLV
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Waratah Digital EEG and Sleep Acquisition Device is a standard polysomnograph with an electroencephalograph designed to capture electrophysiological signals. It utilizes electrodes placed according to the 10-20 International System and offers an optional pulse oximetry function.

This device is intended for use by skilled physicians in clinical settings for long-term unattended monitoring. It has received FDA 510(k) clearance under the identifier K990522.

Other devices from Lamont Medical, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Waratah Digital EEG and Sleep Acquisition Device?

    This device is a standard polysomnograph combined with an electroencephalograph. It is designed to capture electrophysiological signals using electrodes placed according to the 10-20 International System, allowing for long-term unattended monitoring in clinical settings.

  • Does this device include pulse oximetry?

    The device is available with or without an optional pulse oximetry function, providing flexibility depending on the specific monitoring requirements of the clinical environment.

  • Who is intended to operate this device?

    The Waratah system is intended for use by skilled physicians. It is designed for professional clinical settings where long-term unattended monitoring of a patient is required.

  • What is the regulatory status of this device?

    The Waratah Digital EEG and Sleep Acquisition Device has received FDA 510(k) clearance under the identifier K990522, confirming it has been reviewed and found to be substantially equivalent to predicate devices.