510(k) K251508

Telemetry Monitor (iT30, iT50) by Edan Instruments, Inc. — Product Code MHX

K251508 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Telemetry Monitor (iT30, iT50)". The FDA issued a decision of Substantially Equivalent on August 6, 2026. 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.