510(k) Report

Devices descending from K961937

52 later devices reach Simulscope Auscultation and Simulscope Bedside Auscultation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991367Meditron Stethoscope SystemMeditron AS199951—
+2K091732Vrlxp, Model XPDeep Breeze, Ltd.20100—
+2K082528Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc.20090—
+2K072026RNK Electronic StethoscopeRnk Products, Inc.200729—
+2K061495VR Lung ElectrosonographDeep Breeze, Ltd.20072—
+2K031446Jabes Electronic StethoscopeGs Technology Co., Ltd.20033—
+2K013725Meditron II Thesterthoscope SystemMeditron AS200216—
+3K132405Ppa/BT-RB StethoscopeRnk Products, Inc.20130—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K102893PCP/PC StethoscopeRnk Products, Inc.201126—
+3K090493SignalZargis Medical Corp.20091—
+3K073582Vriicu SystemDeep Breeze, Ltd.20081—
+3K062364I-Scope 200Dongjin Medical Co., Ltd.20060—
+3K062481Sereno Electronic StethoscopePishon High Tech Co., Ltd.20061—
+4K160401Tyto StethoscopeTyto Care, Ltd.201621—
+4K132560PCP-Usb StethoscopeRnk Products, Inc.20133—
+4K131287CardiosleeveRijuven Corp20131—
+4K121617SensicardiacDiacoustic Medical (Pty)201210—
+4K100531Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd20100—
+5K202483MyHomeDocMyhomedoc, Ltd.20211—
+5K201299HD StethHd Medical, Inc.20200—
+5K181612Tyto Stethoscope (OTC)Tyto Care, Ltd.201819—
+5K150782AbStats GatewayGi Logic, Inc.20152—
+5K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+6K252089Tyto Stethoscope (G3)Tyto Care, Ltd.20260—
+6K252474Withings BeamO (SCT02)Withings20250—
+6K223785N9+Nonagon, Ltd.20230—
+6K212906HeartBuds Electronic StethoscopeHeartbuds, LLC20230—
+6K223166Medaica M1 Telehealth StethoscopeMedaica, Inc.20230—
+6K211068PrevisEA DeviceEntac Medical, Inc.20211—
+6K200776Eko COREEko Devices, Inc.202013—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K181988eMurmur IDCsd Labs GmbH20197—
+7K261694CORE 300 Digital StethoscopeEko Health, Inc.20260—
+7K233313Keikku Electronic stethoscopeLapsi Health Holding B.V.20240—
+7K231551StethophoneSparrow Acoustics, Inc.20232—
+7K230613SkeeperSmartsound Corporation20230—
+7K230823AusculThing ACCAusculthing OY20230—
+7K230769PrevisEA DeviceEntac Medical, Inc.20230—
+7K220099eClinic StethopodHomediagnostic, LLC20220—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K220766eMurmur Heart AICsd Labs GmbH20221—
+7K220470Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd.20221—
+7K220196Steth IO SpotStratoscientific20220—
+7K210736doctorgram Stethoscope DES-IGv Concepts20212—
+8K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…Shanghai Hulu Devices Co., Ltd.20260—
+8K252284eMurmur Heart AICsd Labs20250—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+8K212975MedWandMedwand Solutions, Inc.20221—
+9K253436c-med0 alphaCosinuss GmbH20260—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—