INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)

K900096 · Artifical Hearing Systems Corp. · EWO · May 31, 1990 · Ear, Nose, Throat

Device Facts

Record IDK900096
Device NameINTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
ApplicantArtifical Hearing Systems Corp.
Product CodeEWO · Ear, Nose, Throat
Decision DateMay 31, 1990
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.1050
Device ClassClass 2

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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