Clearance Summary
FORTEC MI-150 DIGITAL BLOOD PRESSURE METER received FDA 510(k) clearance under submission number K884405, sponsored by Nam Tai Electronic & Electrical Products, 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 1989-05-19.
- Submission: K884405
- Applicant / Sponsor: Nam Tai Electronic & Electrical Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1989-05-19
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.