AUDIOSCOPE #23000 W/71123 CHARGING STAND

K831709 · Welch Allyn, Inc. · ERA · Jun 30, 1983 · Ear, Nose, Throat

Device Facts

Record IDK831709
Device NameAUDIOSCOPE #23000 W/71123 CHARGING STAND
ApplicantWelch Allyn, Inc.
Product CodeERA · Ear, Nose, Throat
Decision DateJun 30, 1983
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.4770
Device ClassClass 1

Regulatory Classification

Identification

An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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