510(k) Report

Devices descending from K002074

27 later devices reach AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091397Ecscope 200Dyansys, Inc.20090—
+1K070614CorscreenViasys Healthcare GmbH200712—
+1K051534Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa200517—
+1K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd.20034—
+2K160840ECG100+, ECG200+Cardioline S.P.A20160—
+2K113234Mobcardio SystemMobhealth Incorporation20110—
+2K093211Carecenter MDCardiac Science Corporation20101—
+2K090936Single-Channel Handheld Electrocardiograph, Model ECG80AContec Medical System Co., Ltd.20090—
+2K082124Carditte MicrotelEt Medical Devices Spa200912—
+2K082380Vicardio 12BEnergy-Lab Technologies GmbH20080—
+2K080734Flowscreen, Flowscreen/Corscreen, Flowscreen CTViasys Healthcare GmbH200810—
+2K062469Voyager 12Del Mar Reynolds Medical, Ltd.20060—
+3K150289Cardioline HD+Cardioline S.P.A20153—
+3K123217CardeascreenCardea Associates, Inc.20130—
+3K091505COR12+Viasys Healthcare GmbH20096—
+3K082539Masterscope, Masterscope Ecg, Masterscope CTCardinal Health Germany 234 GmbH20089—
+4K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.20230—
+4K220526HD+12, HD+15Cardioline S.P.A202301
+4K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH20211—
+4K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC20180—
+4K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH20155Class I
+5K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH20240—
+5K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+5K183369COR12 EcgCorscience GmbH & Co.20180—
+5K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—
+5K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+6K190853Vyntus BODYVyaire Medical, Inc.20190—