Clearance Summary
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series received FDA 510(k) clearance under submission number K163113, sponsored by Grandway Technology (Shenzhen) Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-01-19.
- Submission: K163113
- Applicant / Sponsor: Grandway Technology (Shenzhen) Limited
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2017-01-19
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.