510(k) Report

Devices descending from K150289

3 later devices reach Cardioline HD+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.20230—
+1K220526HD+12, HD+15Cardioline S.P.A202301
+1K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—