The following data is part of a premarket notification filed by Frye Electronics, Inc. with the FDA for Fonix Type 5100 Hearing Aid Analyzer.
| Device ID | K801905 |
| 510k Number | K801905 |
| Device Name: | FONIX TYPE 5100 HEARING AID ANALYZER |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | FRYE ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-11 |
| Decision Date | 1980-08-27 |