510(k) Report

Devices descending from K913749

3 later devices reach Edentrace Airflow 3171/Sleep Lab Airflow 3170 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable…Embla Systems20190—
+1K990321Alphamed Gemini Sensor, Snoring SensorAlphamed, Inc.19991—
+2K040069Dymedix Reusable Airflow/Snore SensorDymedix, Inc.20040—