Clearance Summary
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal received FDA 510(k) clearance under submission number K151874, sponsored by Salter Labs. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2016-04-15.
- Submission: K151874
- Applicant / Sponsor: Salter Labs
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2016-04-15
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.