Clearance Summary
9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT received FDA 510(k) clearance under submission number K930134, 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 1993-04-09.
- Submission: K930134
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1993-04-09
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.