510(k) K242962

Telemetry Monitor 5500 Release 4.0 (867232) by Philips Medizin Systeme Böblingen GmbH — Product Code MHX

K242962 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "Telemetry Monitor 5500 Release 4.0 (867232)". The FDA issued a decision of Substantially Equivalent on May 5, 2025. 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. Philips Medizin Systeme Böblingen GmbH has at least 9 other 510(k) clearances on record.