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Audiometer

by Grason-Stadler, Inc. 510(k)

Active United States

510(k) K843618

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843618 Date3 Dec 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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.

An audiometer is a device used to measure hearing sensitivity and assess auditory function. It is classified as a Class II medical device under FDA regulation 874.1050.

This device received traditional 510(k) clearance (K843618) from the FDA on December 3, 1984, following submission on September 14, 1984. It is manufactured by Grason-Stadler, Inc. and falls under the Ear, Nose, and Throat (ENT) medical specialty.

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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 audiometer used for?

    The audiometer is used to measure hearing sensitivity and assess auditory function, as stated in the device description. It helps clinicians evaluate a patient's hearing thresholds across frequencies to detect hearing loss or monitor auditory health.

  • How was this audiometer cleared for market?

    This audiometer received traditional 510(k) clearance (K843618) from the FDA on December 3, 1984, following submission on September 14, 1984. It was found substantially equivalent to a predicate device, which is the standard pathway for Class II medical devices like this one.

  • Who manufactures this audiometer and where are they located?

    The audiometer is manufactured by Grason-Stadler, Inc., located at 537 Great Rd., P.O. Box 1400, Littleton, MA 01460, United States. This information is derived from the manufacturer and address fields in the device data.

  • What medical specialty is this audiometer intended for?

    The audiometer is intended for use in the Ear, Nose, and Throat (ENT) medical specialty, as indicated by both the medical_specialty_description and advisory_committee_description fields in the device data, which specify ENT as the relevant clinical area.