EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE— 510(k) K081873

Substantially Equivalent

Shenzhen Emperor Electronic Technology Co. , Ltd.

FDA 510(k) clearance K081873 for EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE, Substantially Equivalent on 2008-07-16. Applicant: Shenzhen Emperor Electronic Technology Co. , Ltd..

Clearance details

Applicant: Shenzhen Emperor Electronic Technology Co. , Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2008-07-02
Decision date: 2008-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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.