Clearance Summary
REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T received FDA 510(k) clearance under submission number K041778, sponsored by Maxi-Aids, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-08-31.
- Submission: K041778
- Applicant / Sponsor: Maxi-Aids, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2004-08-31
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.