KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR— 510(k) K102609

Substantially Equivalent

Andon Medical Co., Ltd.

FDA 510(k) clearance K102609 for KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, Substantially Equivalent on 2010-12-09. Applicant: Andon Medical Co., Ltd..

Clearance details

Applicant: Andon Medical Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2010-09-10
Decision date: 2010-12-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tianjin, CN

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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.