Clearance Summary
WINNER SELF-TAKING HOME BLOOD PRESSURE KIT received FDA 510(k) clearance under submission number K942163, sponsored by Winmed Instruments Mfg. 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 1994-12-20.
- Submission: K942163
- Applicant / Sponsor: Winmed Instruments Mfg. Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1994-12-20
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.