EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170

Monitor, Breathing Frequency

EDENTEC CORP.

The following data is part of a premarket notification filed by Edentec Corp. with the FDA for Edentrace Airflow 3171/sleep Lab Airflow 3170.

Pre-market Notification Details

Device IDK913749
510k NumberK913749
Device Name:EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
ClassificationMonitor, Breathing Frequency
Applicant EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie,  MN  55344
ContactGary Syring
CorrespondentGary Syring
EDENTEC CORP. 10252 VALLEY VIEW RD. Eden Prairie,  MN  55344
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-21
Decision Date1992-07-02

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