AUDIOSCOPE #23000 W/71123 CHARGING STAND

Otoscope

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Audioscope #23000 W/71123 Charging Stand.

Pre-market Notification Details

Device IDK831709
510k NumberK831709
Device Name:AUDIOSCOPE #23000 W/71123 CHARGING STAND
ClassificationOtoscope
Applicant WELCH ALLYN, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeERA  
CFR Regulation Number874.4770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-26
Decision Date1983-06-30

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