510(k) K252978

ScioCardio ECG Analysis Platform by Synergen Technology Labs, LLC — Product Code DQK

K252978 is an FDA 510(k) premarket notification submitted by Synergen Technology Labs, LLC for the device "ScioCardio ECG Analysis Platform". The FDA issued a decision of Substantially Equivalent on July 9, 2026. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Synergen Technology Labs, LLC has at least 1 other 510(k) clearance on record.