40-HZ Auditory Evoked Response Test

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K862361 ↗

FDA Product Code

GWJ

Device Class

Class II

Regulation

21 CFR Part 882.1900

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cadwell Laboratories, Inc. →

• What is the primary function of the 40-Hz Auditory Evoked Response Test?

  This device is an evoked response auditory stimulator designed to produce sound stimuli. It is used in clinical settings for evoked response measurements or for electroencephalogram (EEG) activation.

• Who is the manufacturer of this auditory stimulator?

  The device is manufactured by Cadwell Laboratories, Inc., located in Kennewick, Washington.

• Has this device received regulatory authorization?

  Yes, the 40-Hz Auditory Evoked Response Test has received FDA 510(k) clearance under the submission number K862361. It is classified as a Class 2 device under the neurology medical specialty.