The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Beltone Personal Hearing Screener.
| Device ID | K943616 |
| 510k Number | K943616 |
| Device Name: | BELTONE PERSONAL HEARING SCREENER |
| 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 | 1994-07-27 |
| Decision Date | 1995-07-12 |