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Modification to Bio-Logic Sleepscan

by Bio-Logic Systems Corp.

510(k) K983913

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 NumberK983913 Date25 Nov 1998ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

This device is a modification to the Bio-Logic Sleepscan, a standard polysomnograph with electroencephalograph used for recording and analyzing physiological data to diagnose sleep disorders. The modification involves migrating the software from MS-DOS to Microsoft Windows, introducing a standard graphical user interface, enhanced reporting capabilities, and patient database features.

It is supplied as a software modification for use in clinical neurology settings, intended for the diagnosis of sleep disorders through polysomnographic monitoring. The device is classified as a Class II medical device under FDA regulation number 882.1400, with product code OLV, and received FDA 510(k) clearance (K983913) on November 25, 1998, following a determination of substantial equivalence.

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Questions

AI-generated answers, 1 Oct 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 purpose of this modification to the Bio-Logic Sleepscan?

    The modification upgrades the Bio-Logic Sleepscan software from MS-DOS to Microsoft Windows, introducing a standard graphical user interface, enhanced reporting capabilities, and patient database features to improve usability and data management in clinical neurology settings for sleep disorder diagnosis.

  • How is this device supplied and what is it intended for?

    It is supplied as a software modification for use with the Bio-Logic Sleepscan system in clinical neurology settings, intended for recording and analyzing physiological data during polysomnographic monitoring to diagnose sleep disorders.

  • Is this device reusable or single-use, and what are its storage requirements?

    As a software modification, it is not a physical consumable and therefore not classified as single-use or reusable in the traditional sense; it is installed on compatible hardware and should be stored according to standard software and computer equipment guidelines in a clinical environment.