The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Beltone Ode And Beltone Ode Vx; Ode Clearvoice Ic And Beltone Ode Vx Clearvoice Ic; Beltone Ode Clearvoice Anf And.
| Device ID | K940103 |
| 510k Number | K940103 |
| Device Name: | BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND |
| Classification | Hearing Aid, Air Conduction |
| Applicant | BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago, IL 60646 |
| Contact | Robert A Kratochvil |
| Correspondent | Robert A Kratochvil 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 | 1994-01-10 |
| Decision Date | 1994-04-01 |