# K990522: Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and Sleep Acquis

- Pathway: 510(k) (Traditional)
- Applicant: Lamont Medical, Inc.
- Decided: May 19, 1999 after 90 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
61 later devices descend from it; 3 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022274: Carecompanion Patient Station & Nurse Station (2003), 39 descendants of its own
- K041308: Remotenurse Patient Monitoring System (2004), 34 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K061908: Nicoletone System V32 Amplifier (2006), 19 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own

## Indications for use
For long term unattended EEG or other electrophysiological signal monitoring and recording. This device is intended for use by physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologists or the equivalent or Ph.D. level Electroencephalographers. We recommend placement of electrodes in accordance with the 10.20 International System.

Source page: https://510kreport.com/device/K990522
Methodology: https://510kreport.com/methodology