MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)— 510(k) K122013

Substantially Equivalent

Microlife Corp.

FDA 510(k) clearance K122013 for MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M), Substantially Equivalent on 2013-05-13. Applicant: Microlife Corp..

Clearance details

Applicant: Microlife Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2012-07-10
Decision date: 2013-05-13
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.