510(k) K240320

Patient Monitor (RespArray) by Edan Instruments, Inc. — Product Code MHX

K240320 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Patient Monitor (RespArray)". The FDA issued a decision of Substantially Equivalent on June 28, 2024. 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. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.