510(k) Report

Devices descending from K991367

51 later devices reach Meditron Stethoscope System through their predicates, nearest generation first.

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