The following data is part of a premarket notification filed by Western Advanced Technology, Inc. with the FDA for Octotoxic Screener.
| Device ID | K811790 |
| 510k Number | K811790 |
| Device Name: | OCTOTOXIC SCREENER |
| Classification | Generator, Electronic Noise (for Audiometric Testing) |
| Applicant | WESTERN ADVANCED TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETS |
| CFR Regulation Number | 874.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-24 |
| Decision Date | 1981-07-15 |