The following data is part of a premarket notification filed by Widex Hearing Aid Co., Inc. with the FDA for Widex Model M1.
| Device ID | K853793 |
| 510k Number | K853793 |
| Device Name: | WIDEX MODEL M1 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | WIDEX HEARING AID CO., INC. 35-23 24TH ST. Long Island City, NY 11106 |
| Contact | Henry Meltsner |
| Correspondent | Henry Meltsner WIDEX HEARING AID CO., INC. 35-23 24TH ST. Long Island City, NY 11106 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-11 |
| Decision Date | 1985-12-02 |