Clearance Summary
Automatic Wrist Bluetooth Blood Pressure Monitor received FDA 510(k) clearance under submission number K170545, sponsored by Truly Instrument , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-11-21.
- Submission: K170545
- Applicant / Sponsor: Truly Instrument , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2017-11-21
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.