510(k) Report

Devices descending from K080922

3 later devices reach Salter Labs Oral/Nasal Thermal Airflow Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161953ReDe MaskTereopneuma20170—
+1K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor…Salter Labs20160—
+1K092685Pneumotherml, Model: 5800Salter Labs20090—