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Ball Recording Electrode/Stimulation Probe

by Viasys Healthcare, Inc.

510(k) K030517

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 · Abbreviated NumberK030517 Date1 Aug 2003ClearedStatusActive

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  • Withdrawn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
GZK
Device Class
Class II
Regulation
21 CFR Part 882.1340
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Ball Recording Electrode/Stimulation Probe is an electrode, nasopharyngeal device. It is used for recording and stimulation purposes. The device is classified as a class 2 device. The device name is also referred to as an Electrode, Nasopharyngeal.

The Ball Recording Electrode/Stimulation Probe is supplied by Viasys Healthcare, Inc. It has an FDA 510K authorization, with a decision date of August 1, 2003, and a k number of K030517. The device is regulated under the product code GZK and has a regulation number of 882.1340.

Other devices from Viasys Healthcare GmbH

See all devices from Viasys Healthcare GmbH →

Questions

AI-generated answers, 28 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 Ball Recording Electrode/Stimulation Probe used for?

    The Ball Recording Electrode/Stimulation Probe is used for recording and stimulation purposes, specifically as a nasopharyngeal electrode.

  • Is the Ball Recording Electrode/Stimulation Probe a single-use or reusable device?

    The device data does not specify whether the Ball Recording Electrode/Stimulation Probe is single-use or reusable, but it is classified as a class 2 device.

  • What is the regulatory authorization for the Ball Recording Electrode/Stimulation Probe?

    The Ball Recording Electrode/Stimulation Probe has an FDA 510K authorization, with a decision date of August 1, 2003, and a k number of K030517.