Clearance Summary
PRESS-O-TEST received FDA 510(k) clearance under submission number K822102, sponsored by Medi-Swiss 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 1982-11-24.
- Submission: K822102
- Applicant / Sponsor: Medi-Swiss Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1982-11-24
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.