Clearance Summary
UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050 received FDA 510(k) clearance under submission number K850317, sponsored by Nihon Seimitsu Sokki 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 1985-04-16.
- Submission: K850317
- Applicant / Sponsor: Nihon Seimitsu Sokki Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1985-04-16
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.