VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229— 510(k) K935701

Substantially Equivalent

Starkey 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..

Clearance details

Applicant: Starkey Laboratories, Inc.
Product code: Code LXB
Advisory panel: Ear, Nose, Throat
Date received: 1993-11-30
Decision date: 1994-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code LXB

product code LXB

Injury: 2,334
Total: 2,334

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.