KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A— 510(k) K062893

Substantially Equivalent

Shanghai Kodea Economic and Trade Development , Ltd.

FDA 510(k) clearance K062893 for KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A, Substantially Equivalent on 2007-02-05. Applicant: Shanghai Kodea Economic and Trade Development , Ltd..

Clearance details

Applicant: Shanghai Kodea Economic and Trade Development , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-09-27
Decision date: 2007-02-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Shanghai, 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.