BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM

Stimulator, Electrical, 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 Bio-logic Portable Evoked Response System.

Pre-market Notification Details

Device IDK844992
510k NumberK844992
Device Name:BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
ClassificationStimulator, Electrical, Evoked Response
Applicant BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook,  IL  60062
ContactGabriel Raviv
CorrespondentGabriel Raviv
BIO-LOGIC SYSTEMS CORP. 425 HUEHL RD. Northbrook,  IL  60062
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-26
Decision Date1985-06-07

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