EZ-Cover— 510(k) K191491

Substantially Equivalent

Medxpress.Pro

FDA 510(k) clearance K191491 for EZ-Cover, Substantially Equivalent on 2020-06-05. Applicant: Medxpress.Pro.

Clearance details

Applicant: Medxpress.Pro
Product code: Code ITX
Advisory panel: Radiology
Date received: 2019-06-05
Decision date: 2020-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.