510(k) K223049

CardioSTAT® ECG Test Solution by Icentia, Inc. — Product Code DSH

K223049 is an FDA 510(k) premarket notification submitted by Icentia, Inc. for the device "CardioSTAT® ECG Test Solution". The FDA issued a decision of Substantially Equivalent on March 22, 2023. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800.