Clearance Summary
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV received FDA 510(k) clearance under submission number K080177, 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 2008-05-09.
- Submission: K080177
- 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: 2008-05-09
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.