510(k) Report

Devices descending from K013367

8 later devices reach Cardiocollect Portable Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082380Vicardio 12BEnergy-Lab Technologies GmbH20080—
+1K053083Datrix Cardio Wifi ElectrocardiographDatrix20052—
+1K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd.20034—
+2K103427Mobileecg SystemMemtec Corp.20111—
+2K093211Carecenter MDCardiac Science Corporation20101—
+2K062469Voyager 12Del Mar Reynolds Medical, Ltd.20060—
+3K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.20150—
+3K123217CardeascreenCardea Associates, Inc.20130—