K132228

Substantially Equivalent

UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM

Applicant: Samsung Medison Co., Ltd.
Product code: IYO
Advisory panel: Radiology
Date received: 2013-07-17
Decision date: 2013-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.