eCareManager 4.5— 510(k) K211046

Substantially Equivalent

Visicu, Inc.

FDA 510(k) clearance K211046 for eCareManager 4.5, Substantially Equivalent on 2022-06-03. Applicant: Visicu, Inc..

Clearance details

Applicant: Visicu, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2021-04-08
Decision date: 2022-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.