MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.

Stimulator, Auditory, Evoked Response

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Modification To Bio-logic Evoked Potential For Abaer/ Navigator Pro..

Pre-market Notification Details

Device IDK994149
510k NumberK994149
Device Name:MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
ClassificationStimulator, Auditory, Evoked Response
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 CodeGWJ  
CFR Regulation Number882.1900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-08
Decision Date1999-12-27
Summary:summary

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