Clearance Summary
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER received FDA 510(k) clearance under submission number K873765, sponsored by Nam Tai , 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 1987-10-09.
- Submission: K873765
- Applicant / Sponsor: Nam Tai , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 1987-10-09
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.