SPEECH AUDIOMETER RA 226

Audiometer

TRACOR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Speech Audiometer Ra 226.

Pre-market Notification Details

Device IDK780749
510k NumberK780749
Device Name:SPEECH AUDIOMETER RA 226
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 Received1978-05-04
Decision Date1978-05-16

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