WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200— 510(k) K123839

Substantially Equivalent

Ningbo Diaier Electronic Co., Ltd.

FDA 510(k) clearance K123839 for WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200, Substantially Equivalent on 2013-01-11. Applicant: Ningbo Diaier Electronic Co., Ltd..

Clearance details

Applicant: Ningbo Diaier Electronic Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2012-12-13
Decision date: 2013-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Yuyao City, Zhejiang, CN

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.