Clearance Summary
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K914273, sponsored by A&D Engineering, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-02-09.
- Submission: K914273
- Applicant / Sponsor: A&D Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1993-02-09
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.