PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL

Stimulator, Photic, 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 Photic Stimulator Models 580-pscomp,psceeg,psstal.

Pre-market Notification Details

Device IDK874136
510k NumberK874136
Device Name:PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
ClassificationStimulator, Photic, Evoked Response
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactThomas Nall
CorrespondentThomas Nall
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeGWE  
CFR Regulation Number882.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-13
Decision Date1988-03-25

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