eCareManager 4.0.1— 510(k) K153156

Name: FDA 510(k) clearance K153156
Creator: U.S. Food and Drug Administration
Published: 2016-09-30

Substantially Equivalent

Visicu, Inc.

FDA 510(k) clearance K153156 for eCareManager 4.0.1, Substantially Equivalent on 2016-09-30. Applicant: Visicu, Inc.. Device class: 2.

Clearance details

Applicant: Visicu, Inc.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2015-11-02
Decision date: 2016-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

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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.