MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS

About This 510(k) Submission

K130626 is an FDA 510(k) clearance for the MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ge Medical Systems Information Technologies, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 1, 2013, 54 days after receiving the submission on March 8, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.