Clearance Summary
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701 received FDA 510(k) clearance under submission number K870728, 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 1987-03-27.
- Submission: K870728
- Applicant / Sponsor: A&D Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2060
- Decision date: 1987-03-27
Classification & Regulation
This clearance is catalogued under FDA product code DRQ and 21 CFR 870.2060, within the Cardiovascular review panel as a Class II device.