The following data is part of a premarket notification filed by Frye Electronics, Inc. with the FDA for Digital Audiometer/hearing Aid 3100.
| Device ID | K833883 |
| 510k Number | K833883 |
| Device Name: | DIGITAL AUDIOMETER/HEARING AID 3100 |
| Classification | Audiometer |
| Applicant | FRYE ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-09 |
| Decision Date | 1984-02-21 |