Microlife Upper Arm Automatic Digital Blood Pressure Monitor— 510(k) K153450

Substantially Equivalent

Microlife Intellectual Property GmbH

FDA 510(k) clearance K153450 for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Substantially Equivalent on 2015-12-16. Applicant: Microlife Intellectual Property GmbH.

Clearance details

Applicant: Microlife Intellectual Property GmbH
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-11-30
Decision date: 2015-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Widnau, CH

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.