Clearance Summary
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style received FDA 510(k) clearance under submission number K181104, sponsored by Shenzhen Combei Technology 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 2018-08-29.
- Submission: K181104
- Applicant / Sponsor: Shenzhen Combei Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2018-08-29
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.