EMMa Electronic Monitoring Management— 510(k) K153477

Substantially Equivalent

Vitasystems GmbH

FDA 510(k) clearance K153477 for EMMa Electronic Monitoring Management, Substantially Equivalent on 2016-05-25. Applicant: Vitasystems GmbH.

Clearance details

Applicant: Vitasystems GmbH
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2015-12-02
Decision date: 2016-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mannheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.