Clearance Summary
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface received FDA 510(k) clearance under submission number K190560, sponsored by Nonin Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-05-02.
- Submission: K190560
- Applicant / Sponsor: Nonin Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2019-05-02
Classification & Regulation
This clearance is catalogued under FDA product code MUD and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.