Clearance Summary
U.I. OCTOSON received FDA 510(k) clearance under submission number K802030, sponsored by Ausonics Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-10-03.
- Submission: K802030
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2330
- Decision date: 1980-10-03
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.