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