BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST

Audiometer

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Bio-logic Emav Emission Averaging Otoacoustic Test.

Pre-market Notification Details

Device IDK944735
510k NumberK944735
Device Name:BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST
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 Received1994-09-26
Decision Date1994-12-21

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