Clearance Summary
NAMTAI ELECTRONIC BLOOD PRESSURE METER received FDA 510(k) clearance under submission number K924210, sponsored by Nam Tai Electronics (Canada) , 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 1992-11-20.
- Submission: K924210
- Applicant / Sponsor: Nam Tai Electronics (Canada) , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1992-11-20
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.