510(k) K142356

Connex Spot Monitor,901058 Vital Signs Monitor Core by Welch Allyn, Inc. — Product Code MWI

K142356 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "Connex Spot Monitor,901058 Vital Signs Monitor Core". The FDA issued a decision of Substantially Equivalent on December 19, 2014. 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.