Clearance Summary
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 received FDA 510(k) clearance under submission number K012054, sponsored by Sein Electronics 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 2001-08-08.
- Submission: K012054
- Applicant / Sponsor: Sein Electronics Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2001-08-08
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.