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Amplifier Model N3B-EEG

by Honeywell, Inc.

510(k) K771683

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771683 Date20 Sep 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
GWL
Device Class
Class II
Regulation
21 CFR Part 882.1835
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

An Amplifier, Physiological Signal is a device intended to amplify physiological signals for monitoring or diagnostic purposes. This device is classified under medical specialty Neurology and is identified by the model number N3B-EEG.

The device was cleared via the FDA 510(k) process under K number K771683, with a decision date of September 20, 1977, and is classified as a Class II device under regulation number 882.1835. It is manufactured by Honeywell, Inc. and assigned product code GWL.

Other devices from Honeywell, Inc.

See all devices from Honeywell, Inc. →

Questions

AI-generated answers, 22 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 Amplifier Model N3B-EEG used for?

    The Amplifier Model N3B-EEG is intended to amplify physiological signals for monitoring or diagnostic purposes, specifically within the neurology medical specialty as indicated by its classification and product code GWL.

  • How was the Amplifier Model N3B-EEG authorized for market distribution?

    The device was cleared via the FDA 510(k) process under K number K771683, with a decision date of September 20, 1977, based on a determination of substantial equivalence to a predicate device.

  • Is the Amplifier Model N3B-EEG a single-use or reusable device?

    The device data does not specify whether the Amplifier Model N3B-EEG is single-use or reusable; therefore, no conclusion can be drawn about its reusability from the provided information.

  • What regulatory classification applies to the Amplifier Model N3B-EEG?

    The Amplifier Model N3B-EEG is classified as a Class II medical device under regulation number 882.1835, as determined by its FDA 510(k) clearance and product code GWL.

  • Who manufactures the Amplifier Model N3B-EEG and where is it produced?

    The Amplifier Model N3B-EEG is manufactured by Honeywell, Inc., with the facility address listed as 4221 Richmond Rd., NW, Walker, MI 49534, United States.