GALILEO EVOKED POTENTIALRE— 510(k) K963662

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K963662 for GALILEO EVOKED POTENTIALRE, Substantially Equivalent on 1997-02-26. Applicant: Biosound, Inc..

Clearance details

Applicant: Biosound, Inc.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1996-09-13
Decision date: 1997-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.