510(k) K241890

Philips Holter Analysis System by Philips Medizin Systeme Böblingen GmbH — Product Code MLO

K241890 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "Philips Holter Analysis System". The FDA issued a decision of Substantially Equivalent on March 21, 2025. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Philips Medizin Systeme Böblingen GmbH has at least 9 other 510(k) clearances on record.