Clearance Summary
FORTEC MI-100, BLOOD PRESSURE METER received FDA 510(k) clearance under submission number K862200, sponsored by Fortec Electronic Corp./Nam Tai. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-11-18.
- Submission: K862200
- Applicant / Sponsor: Fortec Electronic Corp./Nam Tai
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1986-11-18
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.