Clearance Summary
MODEL 412 ELECTROFLUIDIC MANOMETER received FDA 510(k) clearance under submission number K800222, 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 1980-02-29.
- Submission: K800222
- Applicant / Sponsor: Med-Tek Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1270
- Decision date: 1980-02-29
Classification & Regulation
This clearance is catalogued under FDA product code DXW and 21 CFR 870.1270, within the Cardiovascular review panel as a Class II device.