Clearance Summary
EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR received FDA 510(k) clearance under submission number K904298, sponsored by Medi-Swiss Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-06-21.
- Submission: K904298
- Applicant / Sponsor: Medi-Swiss Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1991-06-21
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.