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Bio-Logic Master II Evoked Response System

by Bio-Logic Systems Corp.

510(k) K073626

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 NumberK073626 Date5 Feb 2008ClearedStatusActive

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  • Withdrawn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, 19 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 Bio-Logic Master II Evoked Response System is an auditory stimulator designed for recording and analyzing evoked responses in human physiology. Classified as an auditory evoked response device, it facilitates the assessment of auditory and hearing-related disorders through precise physiological data acquisition.

This system operates as a Windows-based software application on the Navigator Pro hardware platform, utilizing Auditory Steady State Response (ASSR) modality. It is supplied as a diagnostic tool for clinical use, intended for single-patient evaluations in controlled environments. The device holds FDA 510(k) clearance under registration number 9612330 and is categorized under Class II medical devices (regulation number 882.1900).

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