510(k) K023380

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION by General Electric Medical Systems Information Techn — Product Code DQK

K023380 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "T-WAVE ALTERMANS (TWA) ALGORITHM OPTION". The FDA issued a decision of Substantially Equivalent on December 3, 2002. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.