Clearance Summary
TYPE 9040 SYSTEM ATHENA received FDA 510(k) clearance under submission number K884116, 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 1989-04-26.
- Submission: K884116
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1989-04-26
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.