Clearance Summary
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series received FDA 510(k) clearance under submission number K163648, sponsored by Grandway Technology (Shenzhen) Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-07-07.
- Submission: K163648
- Applicant / Sponsor: Grandway Technology (Shenzhen) Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2017-07-07
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.