Clearance Summary
SYSTEM ATHENA, MODIFICATION received FDA 510(k) clearance under submission number K911611, sponsored by S & W Medico Teknik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-02-05.
- Submission: K911611
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1993-02-05
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.