Clearance Summary
HOME BLOOD PRESSURE KIT, ANEROID received FDA 510(k) clearance under submission number K884420, sponsored by Yamasu Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-08-25.
- Submission: K884420
- Applicant / Sponsor: Yamasu Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1989-08-25
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.