INTERACOUSTICS CLINICAL AUDIOMETER

Audiometer

PRECISION ACOUSTICS IND., INC.

The following data is part of a premarket notification filed by Precision Acoustics Ind., Inc. with the FDA for Interacoustics Clinical Audiometer.

Pre-market Notification Details

Device IDK941920
510k NumberK941920
Device Name:INTERACOUSTICS CLINICAL AUDIOMETER
ClassificationAudiometer
Applicant PRECISION ACOUSTICS IND., INC. 501 FIFTH AVE. New York,  NY  10017
ContactMichael Davis
CorrespondentMichael Davis
PRECISION ACOUSTICS IND., INC. 501 FIFTH AVE. New York,  NY  10017
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-20
Decision Date1994-09-16

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