CEEGRAPH/SLEEPSCAN NETLINK TRAVELER

Standard Polysomnograph With Electroencephalograph

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Ceegraph/sleepscan Netlink Traveler.

Pre-market Notification Details

Device IDK052066
510k NumberK052066
Device Name:CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
ContactNorman E Brunner
CorrespondentNorman E Brunner
BIO-LOGIC SYSTEMS CORP. ONE BIO-LOGIC PLAZA Mundelein,  IL  60060 -3700
Product CodeOLV  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-01
Decision Date2005-08-26
Summary:summary

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