The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Viennatone An, Viennatone As Fidelity F228, Fidelity F229.
| Device ID | K935701 |
| 510k Number | K935701 |
| Device Name: | VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 |
| Classification | Hearing Aid, Bone Conduction |
| Applicant | STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Contact | Rick Stromberg |
| Correspondent | Rick Stromberg STARKEY LABORATORIES, INC. 6700 WASHINGTON AVE. SOUTH Eden Prairie, MN 55344 |
| Product Code | LXB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-30 |
| Decision Date | 1994-05-10 |