510(k) Report

Devices descending from K964554

37 later devices reach Personal Telemedicine Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973873Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc.199736—
+2K1018343M Littmann Scope-to Scope Software System3M Company20102—
+2K034046RNK Telephonic Stethoscope, Model TR-1Rnk Products200432—
+3K1207043M Littmann Telesteth Online Ausculation System3M Company20121—
+3K102893PCP/PC StethoscopeRnk Products, Inc.201126—
+3K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+3K082528Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc.20090—
+3K072026RNK Electronic StethoscopeRnk Products, Inc.200729—
+4K171188Ossler Exam ScopeLr Med, Inc.20170—
+4K160401Tyto StethoscopeTyto Care, Ltd.201621—
+4K132405Ppa/BT-RB StethoscopeRnk Products, Inc.20130—
+4K132560PCP-Usb StethoscopeRnk Products, Inc.20133—
+4K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—
+5K202483MyHomeDocMyhomedoc, Ltd.20211—
+5K181612Tyto Stethoscope (OTC)Tyto Care, Ltd.201819—
+5K150782AbStats GatewayGi Logic, Inc.20152—
+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—
+7K261694CORE 300 Digital StethoscopeEko Health, Inc.20260—
+7K233313Keikku Electronic stethoscopeLapsi Health Holding B.V.20240—
+7K231551StethophoneSparrow Acoustics, Inc.20232—
+7K230613SkeeperSmartsound Corporation20230—
+7K230769PrevisEA DeviceEntac Medical, Inc.20230—
+7K220099eClinic StethopodHomediagnostic, LLC20220—
+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—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+8K212975MedWandMedwand Solutions, Inc.20221—
+9K253436c-med0 alphaCosinuss GmbH20260—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—