THE BELTONE AUDIO SCOUT— 510(k) K915323

Substantially Equivalent

Beltone Electronics Corp.

FDA 510(k) clearance K915323 for THE BELTONE AUDIO SCOUT, Substantially Equivalent on 1992-05-11. Applicant: Beltone Electronics Corp..

Clearance details

Applicant: Beltone Electronics Corp.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1991-11-22
Decision date: 1992-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.