MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC— 510(k) K061471

Substantially Equivalent

Microlife Intellectual Property GmbH

FDA 510(k) clearance K061471 for MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PC, Substantially Equivalent on 2006-09-11. Applicant: Microlife Intellectual Property GmbH.

Clearance details

Applicant: Microlife Intellectual Property GmbH
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2006-05-26
Decision date: 2006-09-11
Decision: Substantially Equivalent
Clearance type: Special
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.