SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER

Ventilatory Effort Recorder

BIO-LOGIC SYSTEMS CORP.

The following data is part of a premarket notification filed by Bio-logic Systems Corp. with the FDA for Sleepscan Airflow Pressure Transducer.

Pre-market Notification Details

Device IDK971501
510k NumberK971501
Device Name:SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
ClassificationVentilatory Effort Recorder
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 CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-24
Decision Date1997-10-14
Summary:summary

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