BELTER BLOOD PRESSURE METER— 510(k) K134029

Substantially Equivalent

Shenzhen Belter Health Measurement and Analysis TE

FDA 510(k) clearance K134029 for BELTER BLOOD PRESSURE METER, Substantially Equivalent on 2014-07-25. Applicant: Shenzhen Belter Health Measurement and Analysis TE.

Clearance details

Applicant: Shenzhen Belter Health Measurement and Analysis TE
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2013-12-31
Decision date: 2014-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, 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.