SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module— 510(k) K171751

Clearance details

Applicant

Capsule Technologie Sas

Product code

Code MWI

Device class

Class 2

Regulation

21 CFR 870.2300

Advisory panel

Cardiovascular

Date received

2017-06-13

Decision date

2017-10-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Andover, MA, US

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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 →