510(k) Report

Devices descending from K021373

11 later devices reach H12+Holter Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051730Matrix Holter System, Model M12Global Instrumentation, LLC20052—
+1K042782Seer MCGe Medical Systems Information Technologies20051—
+1K051686Cardiomem CM 3000-12Getemed Medizin- Und Informationstechnik AG20050—
+1K043010Holter Recorder H3+Mortara Instrument, Inc.20054—
+2K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+2K151787Holter SystemEdan Instruments, Inc.20162—
+2K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+2K101273Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd.20111—
+3K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+3K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+3K131897CV3000 Holter Analysis SystemVales & Hills Biomedical Tech., Ltd.20130—