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Electronystagmograph (Eng Recorder)

by Bio-Logic Systems Corp.

510(k) K850180

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 · Traditional NumberK850180 Date22 Jul 1985ClearedStatusActive

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  • Withdrawn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
GWN
Device Class
Class II
Regulation
21 CFR Part 882.1460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 nystagmograph, a Class 2 neurology medical device used to record eye movements. It is substantially equivalent to a predicate device cleared via the traditional 510(k) pathway.

It is manufactured by Bio-Logic Systems Corp. and holds FDA 510(k) clearance K850180, with product code GWN and regulation number 882.1460. The device was cleared on July 22, 1985, following a 186-day review.

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