The following data is part of a premarket notification filed by Madsen Electronics, Inc. with the FDA for Voyager 522.
| Device ID | K945032 |
| 510k Number | K945032 |
| Device Name: | VOYAGER 522 |
| Classification | Audiometer |
| Applicant | MADSEN ELECTRONICS, INC. 5600 ROWLAND RD. Minnetonka, MN 55343 |
| Contact | Lois Donnay |
| Correspondent | Lois Donnay MADSEN ELECTRONICS, INC. 5600 ROWLAND RD. Minnetonka, MN 55343 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-13 |
| Decision Date | 1995-02-02 |