AUDIO EXPERT AUDIOMETER

K942716 · Beltone Electronics Corp. · EWO · Sep 2, 1994 · Ear, Nose, Throat

Device Facts

Record IDK942716
Device NameAUDIO EXPERT AUDIOMETER
ApplicantBeltone Electronics Corp.
Product CodeEWO · Ear, Nose, Throat
Decision DateSep 2, 1994
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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