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Beltone Series 100 Audiometers

by Beltone Electronics Corp.

510(k) K940216

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 NumberK940216 Date29 Jul 1994ClearedStatusActive

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  • Withdrawn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
EWO
Device Class
Class II
Regulation
21 CFR Part 874.1050
Advisory Committee
Ear, Nose, Throat
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.

The Beltone Series 100 Audiometers are devices classified as audiometers under FDA regulation 874.1050, with product code EWO. They are substantially equivalent to predicate devices and were cleared via the traditional 510(k) pathway.

These devices were manufactured by Beltone Electronics Corp. and received FDA 510(k) clearance K940216 on July 29, 1994. They are intended for use in ear, nose, and throat medical specialty settings as indicated by the advisory committee classification.

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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 is the Beltone Series 100 Audiometer used for?

    The Beltone Series 100 Audiometer is intended for use in ear, nose, and throat medical specialty settings to assess hearing function by measuring auditory thresholds across frequencies, as indicated by its advisory committee classification and FDA product code EWO for audiometers.

  • How was the Beltone Series 100 Audiometer cleared for market release?

    The Beltone Series 100 Audiometer received FDA 510(k) clearance through the traditional pathway under K940216 on July 29, 1994, demonstrating substantial equivalence to a predicate device under regulation 874.1050 with product code EWO.

  • Who manufactures the Beltone Series 100 Audiometer and where is it based?

    The Beltone Series 100 Audiometer is manufactured by Beltone Electronics Corp., located at 4201 W. Victoria St., Chicago, IL 60646, United States, as recorded in the device’s registration and correspondence details.