510(k) K012171— MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

Substantially Equivalent

Visicu, Inc.

Clearance details

Applicant: Visicu, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2001-07-12
Decision date: 2001-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, MD, US

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.