Clearance Summary
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR received FDA 510(k) clearance under submission number K002061, 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 2001-01-19.
- Submission: K002061
- Applicant / Sponsor: A&D Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2001-01-19
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.