510(k) K183638

SmartLinx Vitals Plus Patient Monitoring System by Capsule Technologie — Product Code MWI

K183638 is an FDA 510(k) premarket notification submitted by Capsule Technologie for the device "SmartLinx Vitals Plus Patient Monitoring System". The FDA issued a decision of Substantially Equivalent on Apr 17, 2019. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Capsule Technologie has 8 other 510(k) clearances on record.