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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K913749
FOIA Releasable 510(k) K913749
Device Name EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
Applicant
EDENTEC CORP.
10252 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Applicant Contact Gary Syring
Correspondent
EDENTEC CORP.
10252 VALLEY VIEW RD.
EDEN PRAIRIE,  MN  55344
Correspondent Contact Gary Syring
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received08/21/1991
Decision Date 07/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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