Clearance Summary
A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE received FDA 510(k) clearance under submission number K992808, sponsored by A&D Medical Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-09-01.
- Submission: K992808
- Applicant / Sponsor: A&D Medical Div.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1999-09-01
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.