SmartLinx Vitals Plus Patient Monitoring System
K-Number: K200856 · 2020-07-10
ApplicantCapsule Technologie Sas
Decision Date2020-07-10
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SmartLinx Vitals Plus Patient Monitoring System is a medical device manufactured by Capsule Technologie Sas. It received FDA 510(k) clearance on 2020-07-10 under approval number K200856. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartLinx Vitals Plus Patient Monitoring System?
SmartLinx Vitals Plus Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Capsule Technologie Sas. The 510(k) number is K200856.
When was SmartLinx Vitals Plus Patient Monitoring System approved by the FDA?
SmartLinx Vitals Plus Patient Monitoring System received FDA 510(k) clearance on 2020-07-10, under approval number K200856.
What company makes SmartLinx Vitals Plus Patient Monitoring System?
SmartLinx Vitals Plus Patient Monitoring System is manufactured by Capsule Technologie Sas.
What is the FDA product code for SmartLinx Vitals Plus Patient Monitoring System?
The FDA product code for SmartLinx Vitals Plus Patient Monitoring System is MWI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.