The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Otosonic Cf-2, Cf-2 Ic, Cf-2 Anf, Cf-2 With Improved Class D (delta Amp).
| Device ID | K940177 |
| 510k Number | K940177 |
| Device Name: | OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago, IL 60646 |
| Contact | Robert A Kratochvill |
| Correspondent | Robert A Kratochvill BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago, IL 60646 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-11 |
| Decision Date | 1994-04-01 |