NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT

Electromyograph, Diagnostic

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Navigator & Traveler Evoked Postential Product.

Pre-market Notification Details

Device IDK930328
510k NumberK930328
Device Name:NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
ClassificationElectromyograph, Diagnostic
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactCathy Buhner
CorrespondentCathy Buhner
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeIKN  
CFR Regulation Number890.1375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-22
Decision Date1993-07-02

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