MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR— 510(k) K140572

Substantially Equivalent

Microlife Intellectual Property GmbH, Switzerland

FDA 510(k) clearance K140572 for MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, Substantially Equivalent on 2014-07-02. Applicant: Microlife Intellectual Property GmbH, Switzerland.

Clearance details

Applicant: Microlife Intellectual Property GmbH, Switzerland
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2014-03-06
Decision date: 2014-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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.