510(k) Report

Devices descending from K911097

20 later devices reach PR4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050896H12+ Holter RecorderMortara Instrument, Inc.2005101
+1K021373H12+Holter RecorderMortara Instrument, Inc.200211—
+2K151787Holter SystemEdan Instruments, Inc.20162—
+2K091505COR12+Viasys Healthcare GmbH20096—
+2K051730Matrix Holter System, Model M12Global Instrumentation, LLC20052—
+2K042782Seer MCGe Medical Systems Information Technologies20051—
+2K051686Cardiomem CM 3000-12Getemed Medizin- Und Informationstechnik AG20050—
+2K043010Holter Recorder H3+Mortara Instrument, Inc.20054—
+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—
+3K152626H3+ Holter RecorderMortara Instrument, Inc.20160—
+3K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH20155Class I
+3K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc.20150—
+3K101273Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd.20111—
+4K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+4K183369COR12 EcgCorscience GmbH & Co.20180—
+4K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—
+4K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+4K131897CV3000 Holter Analysis SystemVales & Hills Biomedical Tech., Ltd.20130—
+5K190853Vyntus BODYVyaire Medical, Inc.20190—