SmartLinx Vitals Plus Patient Monitoring System

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Capsule Technologie SAS

The following data is part of a premarket notification filed by Capsule Technologie Sas with the FDA for Smartlinx Vitals Plus Patient Monitoring System.

Pre-market Notification Details

Device IDK200856
510k NumberK200856
Device Name:SmartLinx Vitals Plus Patient Monitoring System
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Capsule Technologie SAS 300 Brickstone Square, Suite 203 Andover,  MA  01810
ContactPeter Kelley
CorrespondentPeter Kelley
Capsule Technologie SAS 300 Brickstone Square, Suite 203 Andover,  MA  01810
Product CodeMWI  
Subsequent Product CodeCCK
Subsequent Product CodeDQA
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-07-10

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