Clearance Summary
TOF-Cuff monitor received FDA 510(k) clearance under submission number K181894, sponsored by Rgb Medical Devices SA. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-05-09.
- Submission: K181894
- Applicant / Sponsor: Rgb Medical Devices SA
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2019-05-09
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.