K974658 is an FDA 510(k) clearance for the INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT. 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 February 25, 1998, 72 days after receiving the submission on December 15, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3320.
| 510(k) Number | K974658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1997 |
| Decision Date | February 25, 1998 |
| Days to Decision | 72 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 |