FM20— 510(k) K110612

Substantially Equivalent

Mediana Co., Ltd.

FDA 510(k) clearance K110612 for FM20, Substantially Equivalent on 2011-11-08. Applicant: Mediana Co., Ltd..

Clearance details

Applicant: Mediana Co., Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2011-03-03
Decision date: 2011-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, Gangwon-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.