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DSP Screening Audiometer

by Micro Audiometrics Corp.

510(k) K924543

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924543 Date26 Feb 1993ClearedStatusActive

Official records

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  • Withdrawn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, 1 Oct 2026

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

The DSP Screening Audiometer is a diagnostic device classified as an audiometer, designed to measure hearing sensitivity. It employs digital signal processing (DSP) technology to assess pure-tone air conduction thresholds across standard audiometric frequencies, aiding in the screening and evaluation of hearing function in clinical or screening settings.

This device is intended for use in clinical environments by trained professionals, such as audiologists or ENT specialists. Supplied as a reusable instrument, it requires no sterilization but must be cleaned and maintained according to manufacturer guidelines. The device is not MRI-safe and is regulated under FDA 510(k) clearance (K924543) with a classification of Class II (EWO). No information on sterility or single-use is provided in the specifications.

Similar devices

Other devices filed under FDA product code EWO (Audiometer).

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