The following data is part of a premarket notification filed by Widex Hearing Aid Co., Inc. with the FDA for Widex Bte Hearing Aid Model Q8.
| Device ID | K885128 |
| 510k Number | K885128 |
| Device Name: | WIDEX BTE HEARING AID MODEL Q8 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | WIDEX HEARING AID CO., INC. 35-23 24TH ST. Long Island City, NY 11106 |
| Contact | Ron Meltsner |
| Correspondent | Ron 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 | 1988-12-12 |
| Decision Date | 1989-03-01 |