Clearance Summary
BLOOD PRESSURE DEVICE, 400 SERIES received FDA 510(k) clearance under submission number K781906, sponsored by Med-Tek 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 1978-11-16.
- Submission: K781906
- Applicant / Sponsor: Med-Tek Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1978-11-16
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.