K940313 is an FDA 510(k) clearance for the PHONIC EAR. This device is classified as a Hearing Aid, Group And Auditory Trainer (Class II - Special Controls, product code EPF).
Submitted by Phonic Ear, Inc. (Petaluma, US). The FDA issued a Cleared decision on March 22, 1994, 57 days after receiving the submission on January 24, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3320.
| 510(k) Number | K940313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1994 |
| Decision Date | March 22, 1994 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EPF — Hearing Aid, Group And Auditory Trainer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3320 |