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Gereonics Biopotential Skin Electrodes

by Gereonics, Inc.

510(k) K861099

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 NumberK861099 Date6 Aug 1986ClearedStatusActive

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  • Withdrawn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
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
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.

Gereonics Biopotential Skin Electrodes are a type of biopotential skin electrode used for transmitting physiological signals. They are designed for precise measurement in applications such as ECG, EOG, ENG, EMG, EEG, GSR, and evoked potentials.

These electrodes are suitable for sleep disorders testing, exercise testing, and pediatric and adult monitoring and recording. They have received FDA 510(k) clearance under K861099, with a decision of substantially equivalent, and are classified under product code DRX by the Cardiovascular advisory committee.

Other devices from Gereonics, Inc.

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 are Gereonics Biopotential Skin Electrodes used for?

    Gereonics Biopotential Skin Electrodes are used to transmit physiological signals in applications such as ECG, EOG, ENG, EMG, EEG, GSR, and evoked potentials. They support sleep disorder testing, exercise testing, and monitoring for both pediatric and adult patients by capturing electrical activity from the skin surface.

  • How are Gereonics Biopotential Skin Electrodes supplied and are they sterile?

    The device data does not specify sterility, packaging, or supply format for Gereonics Biopotential Skin Electrodes. Information about whether they are supplied sterile, single-use, or reusable is not included in the provided authorization or specification details.

  • What regulatory clearance do Gereonics Biopotential Skin Electrodes have?

    Gereonics Biopotential Skin Electrodes have received FDA 510(k) clearance under submission number K861099, with a decision of substantially equivalent. They are classified under product code DRX and were reviewed by the Cardiovascular advisory committee.