The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Tdr-4 Monaural Hearing Aid/wireless Fm Receiver.
| Device ID | K915383 |
| 510k Number | K915383 |
| Device Name: | TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Contact | Thomas Lake |
| Correspondent | Thomas Lake TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Product Code | EPF |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-01-17 |