510(k) K241556

Cardiac Workstation (5000); Cardiac Workstation (7000) by Philips Medizin Systeme Böblingen GmbH — Product Code DPS

K241556 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "Cardiac Workstation (5000); Cardiac Workstation (7000)". The FDA issued a decision of Substantially Equivalent on December 17, 2024. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Philips Medizin Systeme Böblingen GmbH has at least 9 other 510(k) clearances on record.