K022510 is an FDA 510(k) clearance for the FONIX, MODEL 7000. This device is classified as a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II - Special Controls, product code ETW).
Submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on August 27, 2002, 28 days after receiving the submission on July 30, 2002.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3310.
| 510(k) Number | K022510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2002 |
| Decision Date | August 27, 2002 |
| Days to Decision | 28 days |
| Submission Type | Abbreviated |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3310 |