510(k) K231870

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System by Ge Medical Systems Information Technologies, Inc. — Product Code DQK

K231870 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.