eCareCoordinator— 510(k) K171029

Substantially Equivalent

Visicu, Inc.

FDA 510(k) clearance K171029 for eCareCoordinator, Substantially Equivalent on 2017-07-14. Applicant: Visicu, Inc..

Clearance details

Applicant: Visicu, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2017-04-06
Decision date: 2017-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.