Clearance Summary
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 received FDA 510(k) clearance under submission number K080789, sponsored by Sejoy Electronics & Instruments 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 2008-04-03.
- Submission: K080789
- Applicant / Sponsor: Sejoy Electronics & Instruments Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2008-04-03
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.