Clearance Summary
9750 ATHENA ETHERNET OPTION received FDA 510(k) clearance under submission number K934887, sponsored by S & W Medico Teknik A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-01-14.
- Submission: K934887
- Applicant / Sponsor: S & W Medico Teknik A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2330
- Decision date: 1994-01-14
Classification & Regulation
This clearance is catalogued under FDA product code DXK and 21 CFR 870.2330, within the Cardiovascular review panel as a Class II device.