K913494 is an FDA 510(k) clearance for the TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC. This device is classified as a Hearing Aid, Group And Auditory Trainer (Class II — Special Controls, product code EPF).
Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 1, 1991, 87 days after receiving the submission on August 6, 1991.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3320.
| 510(k) Number | K913494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1991 |
| Decision Date | November 01, 1991 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | EPF — Hearing Aid, Group And Auditory Trainer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3320 |