K935400 is an FDA 510(k) clearance for the FONIX 3500 HEARING AID ANALYZER. 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 January 14, 1994, 66 days after receiving the submission on November 9, 1993.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3310.
| 510(k) Number | K935400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1993 |
| Decision Date | January 14, 1994 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| 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 |