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Neurocom Pressure Test System

by Neurocom International, Inc.

510(k) K871652

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 NumberK871652 Date16 Jul 1987ClearedStatusActive

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  • Withdrawn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
ETY
Device Class
Class II
Regulation
21 CFR Part 874.1090
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Neurocom Pressure Test System is a device used for auditory impedance testing. It is designed to measure pressure in the ear to assess middle ear function and detect conditions such as eustachian tube dysfunction.

This device is supplied as a class II medical device with FDA 510(k) clearance K871652, granted on July 16, 1987. It is intended for use in ear, nose, and throat clinical settings and requires appropriate storage conditions as specified by the manufacturer.

Other devices from Neurocom International, Inc.

Questions

AI-generated answers, 28 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 Neurocom Pressure Test System used for?

    The Neurocom Pressure Test System is designed for auditory impedance testing to measure pressure in the ear, assess middle ear function, and detect conditions such as eustachian tube dysfunction in clinical settings.

  • How is the Neurocom Pressure Test System supplied?

    The device is supplied as a class II medical device with FDA 510(k) clearance K871652, intended for use in ear, nose, and throat clinical settings with appropriate storage conditions as specified by the manufacturer.

  • What is the regulatory status of the Neurocom Pressure Test System?

    The Neurocom Pressure Test System has FDA 510(k) clearance K871652, granted on July 16, 1987, and is classified as a class II medical device for auditory impedance testing.

  • What are the specifications of the Neurocom Pressure Test System?

    The device is classified as substantially equivalent with a product code of ETY, intended for ear, nose, and throat specialty use, and requires appropriate storage conditions as specified by the manufacturer.