510(k) K210560

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph by Philips Medical Systems — Product Code DPS

K210560 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph". The FDA issued a decision of Substantially Equivalent on June 30, 2021. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Philips Medical Systems has at least 10 other 510(k) clearances on record.