The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Telex Tinnitus-companion.
| Device ID | K984243 |
| 510k Number | K984243 |
| Device Name: | TELEX TINNITUS-COMPANION |
| Classification | Masker, Tinnitus |
| Applicant | TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Contact | Tom Scheller |
| Correspondent | Tom Scheller TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-27 |
| Decision Date | 1999-01-21 |
| Summary: | summary |