The following data is part of a premarket notification filed by Widex Usa with the FDA for Ie-zen (in Clear Series Hearing Aid).
| Device ID | K110973 |
| 510k Number | K110973 |
| Device Name: | IE-ZEN (IN CLEAR SERIES HEARING AID) |
| Classification | Masker, Tinnitus |
| Applicant | WIDEX USA 2300 CABOT DRIVE, SUITE 415 Lisle, IL 60532 |
| Contact | Francis Kuk |
| Correspondent | Francis Kuk WIDEX USA 2300 CABOT DRIVE, SUITE 415 Lisle, IL 60532 |
| Product Code | KLW |
| CFR Regulation Number | 874.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-06 |
| Decision Date | 2011-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05706069482942 | K110973 | 000 |
| 05706069409802 | K110973 | 000 |
| 05706069409819 | K110973 | 000 |
| 05706069409826 | K110973 | 000 |
| 05706069409833 | K110973 | 000 |
| 05706069409840 | K110973 | 000 |
| 05706069409857 | K110973 | 000 |
| 05706069426618 | K110973 | 000 |
| 05706069426625 | K110973 | 000 |
| 05706069426632 | K110973 | 000 |
| 05706069426649 | K110973 | 000 |
| 05706069426656 | K110973 | 000 |
| 05706069426663 | K110973 | 000 |
| 05706069409796 | K110973 | 000 |