WARD-CSS (v1.2.x)— 510(k) K241958

Substantially Equivalent

Ward 24/7 Aps

FDA 510(k) clearance K241958 for WARD-CSS (v1.2.x), Substantially Equivalent on 2025-02-14. Applicant: Ward 24/7 Aps.

Clearance details

Applicant: Ward 24/7 Aps
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2024-07-03
Decision date: 2025-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.