COCHLEA-SCAN / COCHLEA-SCAN PLUS

Audiometer

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Cochlea-scan / Cochlea-scan Plus.

Pre-market Notification Details

Device IDK061744
510k NumberK061744
Device Name:COCHLEA-SCAN / COCHLEA-SCAN PLUS
ClassificationAudiometer
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactNorman Brunner
CorrespondentNorman Brunner
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-21
Decision Date2006-09-15
Summary:summary

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