ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.

Monitor, Breathing Frequency

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Addition Of Built-in Oxymeter To Sleepscan Prod..

Pre-market Notification Details

Device IDK930790
510k NumberK930790
Device Name:ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
ClassificationMonitor, Breathing Frequency
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 CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-16
Decision Date1994-01-06

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