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Game Audiometry Word Identification Audiometry for Use With Prodigit 2000 Personal Digital Audiometer

by Calmed Technology, Inc.

510(k) K945689

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 NumberK945689 Date8 Feb 1995ClearedStatusActive

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  • Withdrawn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)

Full name
Game Audiometery Word Identification Audiometry for Use with Prodigit(Tm) 2000 Personal Digital Audiometer(Tm)
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, 26 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 Game Audiometry Word Identification Audiometry is an audiometer accessory designed for use with the Prodigit 2000 Personal Digital Audiometer. It facilitates word identification testing as part of an audiometric evaluation.

This device is authorized under FDA 510(k) clearance K945689. It is intended for use in clinical settings for hearing assessment procedures.

Other devices from Calmed Technology, Inc.

Questions

AI-generated answers, 26 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 primary purpose of the Game Audiometry Word Identification accessory?

    This device is designed to facilitate word identification testing as a specific component of a broader audiometric evaluation. It is intended for use in clinical settings to assist in hearing assessment procedures.

  • Is this device compatible with other audiometers?

    No, this specific accessory is designed for use exclusively with the Prodigit 2000 Personal Digital Audiometer.

  • What is the regulatory status of this audiometric accessory?

    The Game Audiometry Word Identification Audiometry is authorized under FDA 510(k) clearance K945689, which confirms its status for use in clinical hearing assessment procedures.