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FDA 510(k) K913749, EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170, by Edentec Corp.

FDA 510(k) K913749, EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170, by Edentec Corp.

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510(K) Number: K913749
Device Name: EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
Manufacturer: Edentec Corp.
Device Classification Name: Monitor, Breathing Frequency
Regulation Number: BZQ
Classification Product Code: KXA
Date Received: 08/21/1991
Decision Date: 07/02/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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