Clearance Summary
Bpump Blood Pressure Cuff received FDA 510(k) clearance under submission number K151810, sponsored by Shenzhen Pump Medical System Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-12-17.
- Submission: K151810
- Applicant / Sponsor: Shenzhen Pump Medical System Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2015-12-17
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.