Clearance Summary
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA received FDA 510(k) clearance under submission number K851616, 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 1985-07-29.
- Submission: K851616
- Applicant / Sponsor: Ausonics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2880
- Decision date: 1985-07-29
Classification & Regulation
This clearance is catalogued under FDA product code JOP and 21 CFR 870.2880, within the Cardiovascular review panel as a Class II device.