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Panbus Digital EEG & Sleep Acquisition Devices

by Lamont Medical, Inc.

510(k) K042364

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 · Special NumberK042364 Date30 Sep 2004ClearedStatusActive

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  • Withdrawn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)

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, 21 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 Panbus Digital EEG & Sleep Acquisition Devices are standard polysomnographs with electroencephalograph capabilities that perform analog-to-digital conversion of signals transmitted via cables to a computer for processing. Healthcare providers use the recorded data to monitor patient neurological and sleep status, aiding in clinical decision-making for sleep and neurological disorders.

These devices are OEM components for constructing EEG/PSG recording systems, with inputs including EEG signals via electrode lead wire sets and auxiliary PSG signals such as airflow, respiratory effort, and limb movement. The device is FDA 510(k) cleared with product code OLV, classified as a standard polysomnograph with electroencephalograph under regulation 882.1400, and intended for use in neurology.

Other devices from Lamont Medical, Inc.