The following data is part of a premarket notification filed by Widex Hearing Aid Co., Inc. with the FDA for Zen Program (mind 440 Hearing Aid).
| Device ID | K080955 |
| 510k Number | K080955 |
| Device Name: | ZEN PROGRAM (MIND 440 HEARING AID) |
| Classification | Masker, Tinnitus |
| Applicant | WIDEX HEARING AID CO., INC. 2300 CABOT DRIVE SUITE 415 Lisle, IL 60532 |
| Contact | Francis Kuk |
| Correspondent | Francis Kuk WIDEX HEARING AID CO., INC. 2300 CABOT DRIVE SUITE 415 Lisle, IL 60532 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-06-27 |
| Summary: | summary |