Viennatone an, Viennatone AS Fidelity F228, Fidelity F229
FDA 510(k) K935701 · Starkey Laboratories, Inc.
510(k) numberK935701
Submission
- Device name
- Viennatone an, Viennatone AS Fidelity F228, Fidelity F229
- Applicant
- Starkey Laboratories, Inc.
Eden Prairie, MN, US - Received
- November 30, 1993
- Decision date
- May 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXB – Hearing Aid, Bone Conduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3302
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…LXB · Traditional | Shokz Health Global Limited | 08/19/2026SE |
| K254296 | Ossiclear (Ossiclear System)LXB · Traditional | Sounduct | 07/22/2026SE |
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…LXB · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/15/2026SE |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)LXB · Traditional | Shenzhen Magnet Technology Co., Ltd. | 06/11/2026SE |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…LXB · Traditional | Cochlear | 05/29/2025SE |
| K243041 | contact forte AlphaLXB · Traditional | Bhm-Tech Produktionsgesellschaft Mbh | 04/25/2025SE |
| K213733 | Ponto 5 SuperPowerLXB · Special | Oticon Medical AB | 12/16/2021SE |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB · Traditional | Cochlear Americas | 09/29/2021SE |
| K211640 | Ponto 5 MiniLXB · Special | Oticon Medical AB | 08/10/2021SE |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…LXB · Traditional | Cochlear Americas | 02/23/2021SE |
More from Cochlear Americas
| 510(k) | Device | Decision |
|---|---|---|
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | 06/19/2020SE |
| K122876 | Multiflex Tinnitus TechnologyKLW · Traditional | 10/31/2012SE |
| K030180 | Crescent Tinnitus Retaining Sound GeneratorKLW · Traditional | 09/17/2003SE |
| K970952 | Precise Impression KitESD · Traditional | 05/02/1997SE |
| K964245 | Precise, Tynmpanette, and Xacto Impression KitsESD · Traditional | 02/04/1997SE |
| K964340 | PORTAREM-3000, PFS-6000EWO · Traditional | 01/10/1997SE |
| K964216 | Starkey TM-3, TM-5 High Frequency Tinnitus MaskerKLW · Traditional | 12/06/1996SE |
| K964244 | Starkey Custom Sequel Programmable and K Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K964214 | Starkey A-13 Sequel Programmable, A-13 K-Amp Programmable Air Conduction Hearing AidsESD · Traditional | 11/27/1996SE |
| K963995 | Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus MaskerKLW · Traditional | 11/26/1996SE |
Questions and answers
When was Viennatone an, Viennatone AS Fidelity F228, Fidelity F229 cleared by the FDA?
Viennatone an, Viennatone AS Fidelity F228, Fidelity F229 (K935701) received a 510(k) decision of Substantially Equivalent on May 10, 1994, 161 days after the submission was received.
What is the product code of K935701?
The FDA product code is LXB – Hearing Aid, Bone Conduction, a Class II (moderate risk) device regulated under 21 CFR 874.3302.