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Stacked ABR for Navigator Pro

by Bio-Logic Systems Corp.

510(k) K030907

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 NumberK030907 Date9 May 2003ClearedStatusActive

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  • Withdrawn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
GWJ
Device Class
Class II
Regulation
21 CFR Part 882.1900
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Stacked ABR for Navigator Pro is a software modification for the Bio-logic Navigator Pro Evoked Potential system. It records EEG signals via scalp electrodes in response to auditory stimuli such as clicks or tones.

This device is supplied as a software modification and is intended for use with the Navigator Pro system in clinical settings. It is classified as a Class II medical device under FDA regulation number 882.1900 and has received FDA 510(k) clearance (K030907) as substantially equivalent to a predicate device.

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Questions

AI-generated answers, 27 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 Stacked ABR for Navigator Pro used for?

    The Stacked ABR for Navigator Pro is a software modification designed to record EEG signals via scalp electrodes in response to auditory stimuli such as clicks or tones. It is intended for use with the Navigator Pro Evoked Potential system in clinical settings to assess auditory pathway function.

  • How is the Stacked ABR for Navigator Pro supplied and what type of device is it?

    The Stacked ABR for Navigator Pro is supplied as a software modification, meaning it is not a physical device but a functional update to the Navigator Pro system. It is classified as a Class II medical device under FDA regulation 882.1900 and is intended for use with the Navigator Pro system in clinical environments.

  • Is the Stacked ABR for Navigator Pro a single-use or reusable product?

    As a software modification, the Stacked ABR for Navigator Pro is not a physical product subject to single-use or reuse limitations. It is installed or enabled on the Navigator Pro system and can be used repeatedly for clinical assessments, subject to the system's operational and maintenance guidelines.