VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM— 510(k) K140339

Substantially Equivalent

Covidien

FDA 510(k) clearance K140339 for VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM, Substantially Equivalent on 2014-04-10. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2014-02-10
Decision date: 2014-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, 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.