The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Otosonic Advanced Full Shield (afs).
| Device ID | K934618 |
| 510k Number | K934618 |
| Device Name: | OTOSONIC ADVANCED FULL SHIELD (AFS) |
| 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 | 1993-09-27 |
| Decision Date | 1993-11-19 |