510(k) K151874

BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal by Salter Labs — Product Code MNR

K151874 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal". The FDA issued a decision of Substantially Equivalent on April 15, 2016. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Salter Labs has at least 10 other 510(k) clearances on record.