BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS

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 Abaer Cub With Integrated Oae & Abr Functions.

Pre-market Notification Details

Device IDK021801
510k NumberK021801
Device Name:BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-03
Decision Date2002-06-27
Summary:summary

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