Clearance Summary
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES received FDA 510(k) clearance under submission number K081159, sponsored by Harvard Medical Devices , 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 2008-08-08.
- Submission: K081159
- Applicant / Sponsor: Harvard Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2008-08-08
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.