TRACOR RA500 AUDIOMETER

Audiometer

TRACOR INSTRUMENTS AUSTIN, INC.

The following data is part of a premarket notification filed by Tracor Instruments Austin, Inc. with the FDA for Tracor Ra500 Audiometer.

Pre-market Notification Details

Device IDK891373
510k NumberK891373
Device Name:TRACOR RA500 AUDIOMETER
ClassificationAudiometer
Applicant TRACOR INSTRUMENTS AUSTIN, INC. 6500 TRACOR LN. Austin,  TX  78725
ContactJack C Foreman
CorrespondentJack C Foreman
TRACOR INSTRUMENTS AUSTIN, INC. 6500 TRACOR LN. Austin,  TX  78725
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-09
Decision Date1989-07-14

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