AUDIOSCOPE 3 MODEL 23300 ACCESSORIES

Audiometer

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Audioscope 3 Model 23300 Accessories.

Pre-market Notification Details

Device IDK884218
510k NumberK884218
Device Name:AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
ClassificationAudiometer
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactJohn Watkins
CorrespondentJohn Watkins
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-06
Decision Date1989-03-10

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