TRACOR RA400 AUDIOMETER

Audiometer

TRACOR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Tracor Ra400 Audiometer.

Pre-market Notification Details

Device IDK822414
510k NumberK822414
Device Name:TRACOR RA400 AUDIOMETER
ClassificationAudiometer
Applicant TRACOR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-11
Decision Date1982-08-30

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