ARC Intensive Care Information System (ARC System)— 510(k) K220117

Substantially Equivalent

Ordinatrum Solutions

FDA 510(k) clearance K220117 for ARC Intensive Care Information System (ARC System), Substantially Equivalent on 2023-06-06. Applicant: Ordinatrum Solutions.

Clearance details

Applicant: Ordinatrum Solutions
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2022-01-14
Decision date: 2023-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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.