VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229— 510(k) K935701
Substantially EquivalentStarkey Laboratories, Inc.
FDA 510(k) clearance K935701 for VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229, Substantially Equivalent on 1994-05-10. Applicant: Starkey Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Starkey Laboratories, Inc.
- Product code
- Code LXB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K250215 — Baha 7 Sound Processor +4 more
More clearances from Starkey Laboratories, Inc.
view allAdverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.