INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26

Tester, Auditory Impedance

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 Impedance Audiometer Az26.

Pre-market Notification Details

Device IDK942007
510k NumberK942007
Device Name:INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26
ClassificationTester, Auditory Impedance
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 CodeETY  
CFR Regulation Number874.1090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-25
Decision Date1994-08-24

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