The following data is part of a premarket notification filed by Frye Electronics, Inc. with the FDA for Fonix ,model 8000.
| Device ID | K093006 |
| 510k Number | K093006 |
| Device Name: | FONIX ,MODEL 8000 |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | FRYE ELECTRONICS, INC. 9826 S.W. TIGARD ST. Tigard, OR 97223 |
| Contact | Kristina Frye |
| Correspondent | Kristina Frye FRYE ELECTRONICS, INC. 9826 S.W. TIGARD ST. Tigard, OR 97223 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2009-12-30 |