VOYAGER 522— 510(k) K945032

Substantially Equivalent

Madsen Electronics, Inc.

FDA 510(k) clearance K945032 for VOYAGER 522, Substantially Equivalent on 1995-02-02. Applicant: Madsen Electronics, Inc..

Clearance details

Applicant: Madsen Electronics, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1994-10-13
Decision date: 1995-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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.