DAIL A HEARING SCREENING TEST

K935719 · Occupational Hearing Services · EWO · Jul 7, 1994 · Ear, Nose, Throat

Device Facts

Record IDK935719
Device NameDAIL A HEARING SCREENING TEST
ApplicantOccupational Hearing Services
Product CodeEWO · Ear, Nose, Throat
Decision DateJul 7, 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
Enter a record ID and click Load to view the document.
100%