510(k) Report

Devices descending from K031182

44 later devices reach Eli 200+ Audicor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101403Eli 250 ElectrocardiographMortara Instrument, Inc.201021
+1K100127Eli 230 ElectrocardiographMortara Instrument, Inc.201061
+1K043074Liberty SystemInovise Medical, Inc.200521
+1K031517Zargis Acoustic CardioscanZargis Medical Corp.200419—
+1K032145Audicor Upgrade SystemInovise Medical, Inc.200313—
+2K160840ECG100+, ECG200+Cardioline S.P.A20160—
+2K143432Cardio-TriTestCardio-Phoenix, Inc.20151—
+2K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+2K122073Eli 280 ElectrocardiographMortara Instrument, Inc.201202
+2K120865Rscribe ElectrocardiographMortara Instrument, Inc.201221
+2K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+2K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+2K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+2K070136Audicor 200 System, Models 200D and 200SInovise Medical, Inc.20070—
+2K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp.200615—
+2K052283Heart STG System and SoftwareStethographics, Inc.200511—
+2K051450Extended Measurements SystemInovise Medical, Inc.20051—
+3K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc.20260—
+3K182790Cardio-TriTest v6.5Cardio-Phoenix, Inc.20180—
+3K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+3K160746CARDIOLINE touchECGCardioline S.P.A20160—
+3K133484Zoll X SeriesZoll Medical Corp20141—
+3K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+3K121617SensicardiacDiacoustic Medical (Pty)201210—
+3K121367Zoll Propaq XMZOLL Medical Corporation201231
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+4K180482ZOLL Propaq MZOLL Medical Corporation20182—
+4K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+4K142915ZOLL X SeriesZOLL Medical Corporation20140—
+4K141774Zoll X SeriesZOLL Medical Corporation20142—
+4K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+4K131287CardiosleeveRijuven Corp20131—
+5K202375ZOLL Propaq MZOLL Medical Corporation20211—
+5K201299HD StethHd Medical, Inc.20200—
+5K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+5K181988eMurmur IDCsd Labs GmbH20197—
+6K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+6K230823AusculThing ACCAusculthing OY20230—
+6K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+6K220766eMurmur Heart AICsd Labs GmbH20221—
+7K252284eMurmur Heart AICsd Labs20250—
+7K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+7K240901StethophoneSparrow Acoustics, Inc.20241—
+8K252595Stethophone ProSparrow Acoustics, Inc.20250—