The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Act-ii Behind The Ear Hearing Aid.
| Device ID | K914418 |
| 510k Number | K914418 |
| Device Name: | ACT-II BEHIND THE EAR HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Contact | Harry Teder |
| Correspondent | Harry Teder TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis, MN 55420 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-03 |
| Decision Date | 1991-10-21 |