The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for U.i. Octoson.
| Device ID | K801675 |
| 510k Number | K801675 |
| Device Name: | U.I. OCTOSON |
| Classification | Booth, Sun Tan |
| Applicant | AUSONICS PTY LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-22 |
| Decision Date | 1980-10-23 |