510(k) K191738

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

K191738 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph". The FDA issued a decision of Substantially Equivalent on September 29, 2020. 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.