510(k) K241411

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) by Welch Allyn, Inc. — Product Code MWI

K241411 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)". The FDA issued a decision of Substantially Equivalent on December 20, 2024. 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. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.