ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM— 510(k) K130232

Substantially Equivalent

Jinxinbao Electronic Co.,Ltd

FDA 510(k) clearance K130232 for ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM, Substantially Equivalent on 2013-09-17. Applicant: Jinxinbao Electronic Co.,Ltd.

Clearance details

Applicant: Jinxinbao Electronic Co.,Ltd
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2013-01-29
Decision date: 2013-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wenzhou, Zhejiang, 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.