EMG NAVIGATOR & EMG TRAVELER

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 Emg Navigator & Emg Traveler.

Pre-market Notification Details

Device IDK893130
510k NumberK893130
Device Name:EMG NAVIGATOR & EMG TRAVELER
ClassificationElectromyograph, Diagnostic
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactRaviv, Ph.d.
CorrespondentRaviv, Ph.d.
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 Received1989-04-25
Decision Date1990-03-20

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