The following data is part of a premarket notification filed by Antares Technical Associates, Inc. with the FDA for Wilson Eustachian Tubal, Sonograph.
| Device ID | K823774 |
| 510k Number | K823774 |
| Device Name: | WILSON EUSTACHIAN TUBAL, SONOGRAPH |
| Classification | Tube, Toynbee Diagnostic |
| Applicant | ANTARES TECHNICAL ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETK |
| CFR Regulation Number | 874.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-14 |
| Decision Date | 1983-01-17 |