The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Binaural Hearing Aid.
| Device ID | K935366 |
| 510k Number | K935366 |
| Device Name: | BINAURAL HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | TELEX COMMUNICATIONS, INC. 8601 E. CORNHUSKER HIGHWAY P.O. BOX 5579 Lincoln, NE 68505 |
| Contact | Bob Basine |
| Correspondent | Bob Basine TELEX COMMUNICATIONS, INC. 8601 E. CORNHUSKER HIGHWAY P.O. BOX 5579 Lincoln, NE 68505 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-04 |
| Decision Date | 1994-01-13 |