SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE

Audiometer

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Sport/audx Oae Test Instrument With Bio-logic Ear Probe.

Pre-market Notification Details

Device IDK974076
510k NumberK974076
Device Name:SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
ClassificationAudiometer
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactNorman E Brunner
CorrespondentNorman E Brunner
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-29
Decision Date1998-01-22
Summary:summary

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