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Amplaid A308 Clinical Audiometer

by Amplus Corp.

510(k) K891988

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 NumberK891988 Date12 Oct 1989ClearedStatusActive

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  • Withdrawn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, 23 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 Amplaid A308 Clinical Audiometer is an audiometer, a device used to assess hearing. It is classified as a device with a device class of 2. The device is used in the medical specialty of Ear, Nose, Throat.

The Amplaid A308 Clinical Audiometer is supplied with a registration number and is regulated under the regulation number 874.1050. It has been authorized with an FDA 510K clearance. The device is used in a clinical setting and its storage and use are subject to standard clinical protocols.

Other devices from Amplus Corp.

Questions

AI-generated answers, 23 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 Amplaid A308 Clinical Audiometer used for?

    The Amplaid A308 Clinical Audiometer is used to assess hearing in a clinical setting, specifically in the medical specialty of Ear, Nose, Throat.

  • Is the Amplaid A308 Clinical Audiometer sterile?

    The device data does not specify the sterility of the Amplaid A308 Clinical Audiometer, but its storage and use are subject to standard clinical protocols.

  • What regulatory clearance does the Amplaid A308 Clinical Audiometer have?

    The Amplaid A308 Clinical Audiometer has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.

  • What is the device class of the Amplaid A308 Clinical Audiometer?

    The Amplaid A308 Clinical Audiometer is classified as a device with a device class of 2.