Clearance Summary
PATIENT CABLE received FDA 510(k) clearance under submission number K080112, sponsored by Med-Dyne. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-06-20.
- Submission: K080112
- Applicant / Sponsor: Med-Dyne
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2008-06-20
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.