GSI AUDERA

K011135 · Nicolet Biomedical · EWO · Jul 26, 2001 · Ear, Nose, Throat

Device Facts

Record IDK011135
Device NameGSI AUDERA
ApplicantNicolet Biomedical
Product CodeEWO · Ear, Nose, Throat
Decision DateJul 26, 2001
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

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