K062758

Substantially Equivalent

OWL URF-3AP

Applicant: Diros Technology, Inc.
Product code: GXD
Advisory panel: Neurology
Date received: 2006-09-15
Decision date: 2006-09-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Markham, Ontario, CA

Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

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.