Clearance Summary
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors received FDA 510(k) clearance under submission number K151953, sponsored by A&D Company, 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 2016-04-13.
- Submission: K151953
- Applicant / Sponsor: A&D Company, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2016-04-13
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.