Clearance Summary
Meditech ABPM-06 (BP6) received FDA 510(k) clearance under submission number K201332, sponsored by Meditech , 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 2021-02-10.
- Submission: K201332
- Applicant / Sponsor: Meditech , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2021-02-10
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.