ABPM 7100, Hypertension Management Software— 510(k) K153557

Substantially Equivalent

I.E.M. GmbH

FDA 510(k) clearance K153557 for ABPM 7100, Hypertension Management Software, Substantially Equivalent on 2016-07-19. Applicant: I.E.M. GmbH.

Clearance details

Applicant: I.E.M. GmbH
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2015-12-14
Decision date: 2016-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stolberg, DE

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.