510(k) K210204

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

K210204 is an FDA 510(k) premarket notification submitted by Capsule Technologie Sas for the device "Capsule Vitals Plus Patient Monitoring System". The FDA issued a decision of Substantially Equivalent on Oct 19, 2021. 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 Sas has 8 other 510(k) clearances on record.