BIO-LOGIC AUTOMATIC EVENT ANALYSIS

Automatic Event Detection Software For Full-montage Electroencephalograph

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 Automatic Event Analysis.

Pre-market Notification Details

Device IDK951594
510k NumberK951594
Device Name:BIO-LOGIC AUTOMATIC EVENT ANALYSIS
ClassificationAutomatic Event Detection Software For Full-montage Electroencephalograph
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 CodeOMB  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-06
Decision Date1995-08-22

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