The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Telex Tdr-7aa Binaural Hear Aid/wireless Fm Rec.
| Device ID | K913495 |
| 510k Number | K913495 |
| Device Name: | TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC |
| Classification | Hearing Aid, Group And Auditory Trainer |
| Applicant | TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Contact | Thomas J Lake |
| Correspondent | Thomas J 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 | 1991-08-06 |
| Decision Date | 1991-11-01 |