510(k) K221879

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 by Caf Medical Solutions, Inc. — Product Code MHX

K221879 is an FDA 510(k) premarket notification submitted by Caf Medical Solutions, Inc. for the device "Patient Monitor, models LM-8, LM-10, LM-12 and LM-15". The FDA issued a decision of Substantially Equivalent on Aug 10, 2022. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Caf Medical Solutions, Inc. has 2 other 510(k) clearances on record.