Clearance Summary
AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 received FDA 510(k) clearance under submission number K994423, sponsored by Vsm Medtech , 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 2000-03-28.
- Submission: K994423
- Applicant / Sponsor: Vsm Medtech , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2000-03-28
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.