The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Beltone Series 100 Audiometers.
| Device ID | K940216 |
| 510k Number | K940216 |
| Device Name: | BELTONE SERIES 100 AUDIOMETERS |
| Classification | Audiometer |
| 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 | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-14 |
| Decision Date | 1994-07-29 |