The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for U.i. Octoson.
| Device ID | K802030 |
| 510k Number | K802030 |
| Device Name: | U.I. OCTOSON |
| Classification | Echocardiograph |
| Applicant | AUSONICS PTY LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-21 |
| Decision Date | 1980-10-03 |