DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11— 510(k) K014141

Substantially Equivalent

Digibio Technology Corp.

FDA 510(k) clearance K014141 for DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11, Substantially Equivalent on 2002-09-13. Applicant: Digibio Technology Corp..

Clearance details

Applicant: Digibio Technology Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-12-17
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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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.