V10— 510(k) K152659

Substantially Equivalent

Mediana Co., Ltd.

FDA 510(k) clearance K152659 for V10, Substantially Equivalent on 2016-08-25. Applicant: Mediana Co., Ltd..

Clearance details

Applicant: Mediana Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-09-17
Decision date: 2016-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.