510(k) K960143

G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY by GE Medical Systems — Product Code DWS

K960143 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY". The FDA issued a decision of Substantially Equivalent (kit) on April 9, 1996. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. GE Medical Systems has at least 10 other 510(k) clearances on record.