# K042364: Panbus Digital Eeg & Sleep Acquisition Devices

- Pathway: 510(k) (Special)
- Applicant: Lamont Medical, Inc.
- Decided: Sep 30, 2004 after 30 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
Longest line of descent: 2 generations back to K001324 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990522: Waratah Digital Eeg and Sleep Acquisition Devices with, or Without, Pulse Oximetry,Cardinal Digital Eeg and Sleep Acquis, Lamont Medical, Inc. (1999) Summary page 1.
- K023771: SYNAMPS2, Neuroscan (2003) Summary page 1.

## 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 Neurophysiologist or the equivalent or Ph.D. level Electroencephalographers. - We recommend placement of electrodes in accordance with the 10.20 Intemational System.

Source page: https://510kreport.com/device/K042364
Methodology: https://510kreport.com/methodology