Clearance Summary
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K061456, sponsored by A&D Engineering, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-06-21.
- Submission: K061456
- Applicant / Sponsor: A&D Engineering, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2006-06-21
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.