Stethoscope, Electronic
FDA product code DQD · Class II (moderate risk) · 21 CFR 870.1875 · Cardiovascular
156510(k) clearances
0PMA approvals
0recalls
Manufacturers
- 3M Company 6
- Rnk Products, Inc. 6
- Zargis Medical Corp. 5
- Eko Devices, Inc. 5
- Chip Ideas Electronics S.L. 5
- Swartz Medical Equipment 4
- Sparrow Acoustics, Inc. 4
- Andromed, Inc. 4
- Amdia Medical Products 4
- Eko Health, Inc. 3
- Csd Labs GmbH 3
- Imediplus, Inc. 3
- Tyto Care , Ltd. 3
- American Diagnostic Corp. 3
- M3Dicine Pty , Ltd. 2
- Doctor'S Research Group, Inc. 2
- Stratoscientific, Inc. 2
- Inovise Medical, Inc. 2
- Conphar, Inc. 2
- Diacoustic Medical Devices (Pty) , Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional | Shanghai Hulu Devices Co., Ltd. | 07/31/2026SE |
| K261694 | CORE 300 Digital StethoscopeDQD · Traditional | Eko Health, Inc. | 07/23/2026SE |
| K252915 | AiSteth®DQD · Traditional | Ai Health Highway India Pvt., Ltd. | 05/22/2026SE |
| K252089 | Tyto Stethoscope (G3)DQD · Traditional | Tyto Care , Ltd. | 03/12/2026SE |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional | Kneevoice, Inc. | 02/06/2026SE |
| K252284 | eMurmur Heart AIDQD · Traditional | Csd Labs | 12/19/2025SE |
| K252595 | Stethophone ProDQD · Special | Sparrow Acoustics, Inc. | 09/12/2025SE |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional | Eko Health, Inc. | 08/12/2025SE |
| K242971 | AccurSound Electronic Stethoscope (AS101)DQD · Traditional | Heroic Faith International , Ltd. | 11/25/2024SE |
| K240901 | StethophoneDQD · Traditional | Sparrow Acoustics, Inc. | 09/19/2024SE |
| K233313 | Keikku Electronic stethoscopeDQD · Traditional | Lapsi Health Holding B.V. | 04/10/2024SE |
| K233609 | CORE 500 Digital StethoscopeDQD · Traditional | Eko Health, Inc. | 03/28/2024SE |
| K231551 | StethophoneDQD · Traditional | Sparrow Acoustics, Inc. | 10/12/2023SE |
| K230613 | SkeeperDQD · Traditional | Smartsound Corporation | 08/02/2023SE |
| K230823 | AusculThing ACCDQD · Traditional | Ausculthing OY | 07/12/2023SE |
| K230111 | CORE 500 Digital StethoscopeDQD · Traditional | Eko Devices, Inc. | 05/26/2023SE |
| K230769 | PrevisEA DeviceDQD · Traditional | Entac Medical, Inc. | 05/19/2023SE |
| K223785 | N9+DQD · Traditional | Nonagon , Ltd. | 04/14/2023SE |
| K222871 | Stethophone v1DQD · Traditional | Sparrow Acoustics, Inc. | 03/29/2023SE |
| K221805 | AccurSound Electronic Stethoscope AS-101DQD · Traditional | Heroic Faith International , Ltd. | 03/23/2023SE |
| K212906 | HeartBuds Electronic StethoscopeDQD · Traditional | Heartbuds, LLC | 03/14/2023SE |
| K223166 | Medaica M1 Telehealth StethoscopeDQD · Traditional | Medaica, Inc. | 01/19/2023SE |
| K220466 | ibiomedi Electronic Stethoscope ES-2020DQD · Traditional | Sound Land Corp. | 11/03/2022SE |
| K220099 | eClinic StethopodDQD · Traditional | Homediagnostic, LLC | 10/20/2022SE |
| K213794 | Eko Murmur Analysis Software (EMAS)DQD · Traditional | Eko Devices, Inc. | 06/29/2022SE |
| K220766 | eMurmur Heart AIDQD · Special | Csd Labs GmbH | 05/31/2022SE |
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope…DQD · Traditional | Chip Ideas Electronics S.L. | 05/26/2022SE |
| K220470 | Smart Wireless StethoscopeDQD · Traditional | Shanghai Hulu Devices Co., Ltd. | 05/23/2022SE |
| K220196 | Steth IO SpotDQD · Traditional | Stratoscientific | 03/24/2022SE |
| K212709 | VoqX Electronic StethoscopeDQD · Traditional | Sanolla , Ltd. | 03/15/2022SE |
| K212013 | eKuore Pro 4T - REF EP0098DQD · Special | Chip Ideas Electronics S.L. | 11/10/2021SE |
| K211068 | PrevisEA DeviceDQD · Traditional | Entac Medical, Inc. | 08/04/2021SE |
| K210736 | doctorgram Stethoscope DES-IDQD · Traditional | Gv Concepts | 07/27/2021SE |
| K202483 | MyHomeDocDQD · Traditional | Myhomedoc , Ltd. | 03/23/2021SE |
| K201742 | eKuore One Wireless Electronic Interface for stethoscopeDQD · Traditional | Chip Ideas Electronics S.L. | 11/24/2020SE |
| K203007 | eKuore Pro SeriesDQD · Traditional | Chip Ideas Electronics S.L. | 10/30/2020SE |
| K193631 | Stethee Pro 1, Stethee Pro Software SystemDQD · Traditional | M3Dicine Pty , Ltd. | 10/09/2020SE |
| K200862 | Feelix StethoscopeDQD · Traditional | Sonavi Labs, Inc. | 09/14/2020SE |
| K201299 | HD StethDQD · Traditional | Hd Medical, Inc. | 07/10/2020SE |
| K200776 | Eko COREDQD · Traditional | Eko Devices, Inc. | 04/06/2020SE |
| K191667 | Electronic StethoscopeDQD · Traditional | Hefei Mintti Medical Technology Co., Ltd. China | 12/18/2019SE |
| K183710 | Vivio SystemDQD · Traditional | Avicena, LLC | 10/04/2019SE |
| K181988 | eMurmur IDDQD · Traditional | Csd Labs GmbH | 04/17/2019SE |
| K181882 | eKuore One electronic interface for stethoscopeDQD · Traditional | Chip Ideas Electronics S.L. | 03/27/2019SE |
| K181612 | Tyto Stethoscope (OTC)DQD · Traditional | Tyto Care , Ltd. | 12/17/2018SE |
| K182196 | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model…DQD · Traditional | Imediplus, Inc. | 09/11/2018SE |
| K173663 | Electronic Stethoscope DS3011ADQD · Abbreviated | Imediplus, Inc. | 08/17/2018SE |
| K173448 | CliniCloud StethoscopeDQD · Traditional | Stethocloud Pty.Ltd (Clinicloud) | 01/25/2018SE |
| K172296 | Stethee ProDQD · Traditional | M3Dicine Pty , Ltd. | 10/30/2017SE |
| K170928 | CADence SystemDQD · Traditional | Aum Cardiovascular, Inc. | 08/03/2017SE |
| K170874 | Eko Model E5 System (EME5), Eko DUODQD · Traditional | Eko Devices, Inc. | 05/19/2017SE |
| K162589 | Adscope 658 Electronic StethoscopeDQD · Traditional | American Diagnostic Corp. | 03/10/2017SE |
| K160401 | Tyto StethoscopeDQD · Traditional | Tyto Care , Ltd. | 10/19/2016SE |
| K160023 | Electronic Stethoscope DS301DQD · Traditional | Imediplus, Inc. | 09/30/2016SE |
| K160016 | Steth IODQD · Traditional | Stratoscientific, Inc. | 07/15/2016SE |
| K150782 | AbStats GatewayDQD · Traditional | Gi Logic, Inc. | 12/14/2015SE |
| K151319 | Eko Electronic Stethoscope SystemDQD · Traditional | Eko Devices, Inc. | 08/28/2015SE |
| K123148 | Parace MD Ekoscope IS100DQD · Traditional | Parace, LLC | 11/19/2013SE |
| K132560 | Pcp-Usb StethoscopeDQD · Traditional | Rnk Products, Inc. | 10/11/2013SE |
| K132405 | Ppa/Bt-Rb StethoscopeDQD · Traditional | Rnk Products, Inc. | 10/11/2013SE |
| K131044 | Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDQD · Traditional | Diacoustic Medical Devices (Pty) , Ltd. | 09/04/2013SE |
| K131287 | CardiosleeveDQD · Traditional | Rijuven Corp | 06/24/2013SE |
| K121144 | Electronic StethoscopeDQD · Traditional | Sharp Corporation | 09/26/2012SE |
| K121617 | SensicardiacDQD · Traditional | Diacoustic Medical (Pty) | 07/27/2012SE |
| K110704 | SensiDQD · Traditional | Diacoustic Medical Devices (Pty) , Ltd. | 06/24/2011SE |
| K103499 | A ScopeDQD · Traditional | Active Signal Technologies, Inc. | 03/31/2011SE |
| K103516 | Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0DQD · Traditional | Inovise Medical, Inc. | 02/04/2011SE |
| K102893 | Pcp/Pc StethoscopeDQD · Traditional | Rnk Products, Inc. | 01/20/2011SE |
| K100531 | Viscope, Model 100P,100SDQD · Traditional | Hd Medical Services (India) Pvt.Ltd | 07/21/2010SE |
| K091972 | Milscope Floating Mass Stethoscope, Model 300-01DQD · Traditional | Stethoscope Technologies, Inc. | 09/23/2009SE |
| K090493 | SignalDQD · Traditional | Zargis Medical Corp. | 08/07/2009SE |
| K083903 | 3M Littmann Electronic Stethoscope, Model 3200DQD · Traditional | 3M Company | 07/15/2009SE |
| K082528 | Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemDQD · Traditional | Noble Anesthesia-Air, Inc. | 03/06/2009SE |
| K082771 | Protron Technologies, LLC StethotronDQD · Traditional | Protron Technologies, LLC | 02/27/2009SE |
| K083309 | Zargis Acoustic Cardioscan, Version 9.33DQD · Special | Zargis Medical Corp. | 02/13/2009SE |
| K081032 | Tr-Usb Telephonic StethoscopeDQD · Traditional | Rnk Products, Inc. | 06/06/2008SE |
| K070550 | Ausco ES-3100DQD · Traditional | Koratek Company, Ltd. | 11/06/2007SE |
| K072026 | RNK Electronic StethoscopeDQD · Traditional | Rnk Products, Inc. | 10/26/2007SE |
| K062364 | I-Scope 200DQD · Traditional | Dongjin Medical Co., Ltd. | 12/06/2006SE |
| K062481 | Sereno Electronic StethoscopeDQD · Traditional | Pishon High Tech Co., Ltd. | 10/16/2006SE |
| K060321 | Adscope 657BK Electronic Stethoscope, Model 657BKDQD · Traditional | American Diagnostic Corp. | 05/15/2006SE |
| K060197 | Zargis Acoustic Cardioscan (Zac), Model Zac 6.28DQD · Special | Zargis Medical Corp. | 03/29/2006SE |
| K052283 | Heart STG System and SoftwareDQD · Traditional | Stethographics, Inc. | 12/23/2005SE |
| K051450 | Extended Measurements SystemDQD · Traditional | Inovise Medical, Inc. | 11/10/2005SE |
| K050097 | Techno-Scope Visual StethoscopeDQD · Traditional | Techtrade, LLC | 09/30/2005SE |
| K051790 | 3M Littmann Electronic Stethoscope, Model 4100DQD · Special | 3M Company | 07/25/2005SE |
| K050169 | HL 200 Electronic StethoscopeDQD · Traditional | Health & Life Co., Ltd. | 04/05/2005SE |
| K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000DQD · Special | 3M Company | 02/22/2005SE |
| K041934 | 3M Littmann Electronic Stethoscope, Model 3000DQD · Traditional | 3M Company | 10/15/2004SE |
| K042128 | Modification to Zargis Acoustic Cardioscan (Zac)DQD · Special | Zargis Medical Corp. | 09/08/2004SE |
| K031517 | Zargis Acoustic CardioscanDQD · Traditional | Zargis Medical Corp. | 05/26/2004SE |
| K034046 | RNK Telephonic Stethoscope, Model TR-1DQD · Traditional | Rnk Products | 03/10/2004SE |
| K032230 | Rhythm Digital Electronic StethoscopeDQD · Traditional | Thinklabs, Inc. | 11/26/2003SE |
| K031446 | Jabes Electronic StethoscopeDQD · Traditional | Gs Technology Co., Ltd. | 10/31/2003SE |
| K023759 | Cardiovascular Sonospectrographic AnalyzerDQD · Traditional | Sonomedica | 05/06/2003SE |
| K023637 | Tytan Electronic Stethoscopes (Model #600)DQD · Traditional | Tytan Medical Corp. | 02/26/2003SE |
| K021087 | Hippocrat Electronic Stethoscope, Model DR300; Sounds Easy Auscultation SoftwareDQD · Abbreviated | Erecords Limited | 10/11/2002SE |
| K022298 | I-Stethos LinkDQD · Abbreviated | Andromed, Inc. | 10/01/2002SE |
| K021389 | Biological Sound Monitor (BSM) SensorDQD · Abbreviated | Andromed, Inc. | 10/01/2002SE |
| K013725 | Meditron II Thesterthoscope SystemDQD · Traditional | Meditron AS | 01/30/2002SE |
| K012304 | Adc 656 Electronic StethoscopeDQD · Traditional | American Diagnostic Corp. | 11/01/2001SE |
| K010729 | Agilent Electronic Stethoscope, Models M4532A and M4533ADQD · Traditional | Andromed, Inc. | 10/26/2001SE |
| K011898 | E-Steth Electronic StethoscopeDQD · Traditional | E-Med Innovations, Inc. | 09/14/2001SE |
| K003723 | 3M LittmannDQD · Abbreviated | 3M Company | 03/27/2001SE |
| K003485 | Care Provider Station Addition of Weight ScaleDQD · Traditional | Cybercare Technologies, Inc. | 01/11/2001SE |
| K002984 | EHC400 Desktop Patient Station; EHC600 Care Provider StationDQD · Traditional | Cybercare Technologies, Inc. | 12/18/2000SE |
| K002047 | DRG Puretone Stethoscope with DRG Antimicrobial, Stethoscope Diaphragm, Model…DQD · Traditional | Doctor'S Research Group, Inc. | 11/22/2000SE |
| K001788 | Estation Electronic Stethoscope, Model DR200DQD · Traditional | Erecords Enterprises | 11/03/2000SE |
| K001306 | Stethos, Model Stxxyyzz or 001 XXX, Stethos Link, Model Slxxyyzz or 002 XXXDQD · Traditional | Andromed, Inc. | 07/20/2000SE |
| K993623 | Gemini EDQD · Traditional | Allen Medical Instruments Corp. | 06/23/2000SE |
| K991756 | 3 Channel Knee Electronic Amplified StethoscopeDQD · Traditional | Bio-Research Associates, Inc. | 12/10/1999SE |
| K991714 | DRG Conventional Electronic Digital Stethoscope, Model Echop 200-00DQD · Traditional | Doctor'S Research Group, Inc. | 12/10/1999SE |
| K991367 | Meditron Stethoscope SystemDQD · Traditional | Meditron AS | 07/19/1999SE |
| K990809 | Cadiscope Electronic StethoscopeDQD · Traditional | Caditec AG | 06/09/1999SE |
| K961848 | 3M Littmann Electronic StethoscopeDQD · Traditional | Minnesota Mining and Mfg. Co. | 09/26/1997SE |
| K963418 | Transmedica Model 100 Digital Electronic StethoscopeDQD · Traditional | Transmedica, Inc. | 05/02/1997SE |
| K963678 | Caretone IIDQD · Traditional | American Telecare, Inc. | 02/24/1997SE |
| K961937 | Simulscope Auscultation and Simulscope Bedside Auscultation SystemDQD · Traditional | Delphi Consulting Group | 12/09/1996SE |
| K963621 | StethosDQD · Traditional | Theratechnologies, Inc. | 12/04/1996SE |
| K961857 | Labtron Electromax Electronic Stethoscope Model No. 04-1060DQD · Traditional | Graham-Field, Inc. | 07/03/1996SE |
| K961301 | E-Scope Electronic Stethoscope Model 718-7120DQD · Traditional | Delphi Consulting Group | 06/11/1996SE |
| K953833 | Life Sound Sensor Amplifier-LisaDQD · Traditional | Flowscan, Inc. | 12/05/1995SE |
| K950760 | Analyst, Model DSP 300DQD · Traditional | Heart Sounds, Inc. | 10/31/1995SE |
| K953218 | Ausculator GPSDQD · Traditional | Lyte Industries, Inc. | 09/18/1995SE |
| K945638 | Telphonic StethoscopeDQD · Traditional | American Telecare, Inc. | 05/17/1995SE |
| K941763 | Electronic-Amplified StethoscopeDQD · Traditional | Hsues' Brothers Medical, Inc. | 09/06/1994SE |
| K920009 | 3M Littmann Graphic Display SystemDQD · Traditional | 3M Health Care, Ltd. | 10/21/1992SE |
| K893557 | Adam (Acoustical Device for Anatomical Monitoring)DQD · Traditional | Medical Monitors, Inc. | 03/19/1990SE |
| K892890 | Steth-Shield(Tm)DQD · Traditional | North East Technology | 12/01/1989SE |
| K882716 | Procedure Packs Solution Administration SetsDQD · Traditional | Procedure Packs, Inc. | 09/16/1988SE |
| K874726 | Mascot Stethoscope ProbeDQD · Traditional | Imex Medical Systems, Inc. | 03/31/1988SE |
| K870810 | Dorches(Tm) Lifesound(Tm)DQD · Traditional | Centauri Manufacturing, Inc. | 06/29/1987SE |
| K864278 | Ds-Ii Digital Sonography SystemDQD · Traditional | Intl. Acoustics, Inc. | 06/10/1987SE |
| K860994 | Decitel AusculscopeDQD · Traditional | Bloomfield Research and Development, Inc. | 11/07/1986SE |
| K854772 | Transcor (TM) Radio-StethoscopeDQD · Traditional | K & S Medicorp | 05/13/1986SE |
| K854356 | Stethoscope Electronic Stethoscope SphygmomanometeDQD · Traditional | Fontaine Industries, Inc. | 05/05/1986SE |
| K844804 | Lifesound - Electronic StethoscopeDQD · Traditional | Biomedical Concepts, Inc. | 02/13/1985SE |
| K842705 | MX2 Electronic StethoscopeDQD · Traditional | Medmax, Inc. | 01/23/1985SE |
| K831763 | Max IDQD · Traditional | Trade Max, Inc. | 01/27/1984SE |
| K832882 | Dif-StetDQD · Traditional | Intersect Systems, Inc. | 12/06/1983SE |
| K812148 | Electronic Stethoscope #S-50DQD · Traditional | Syphgmostat | 08/25/1981SE |
| K801189 | Conphar Supertone StethoscopeDQD · Traditional | Conphar, Inc. | 06/04/1980SE |
| K801165 | Hyperstethoscope, Model Z 00DQD · Traditional | Demonbinder Electronics | 05/23/1980SE |
| K792112 | Conphar StethscopeDQD · Traditional | Conphar, Inc. | 12/04/1979SE |
| K791338 | Dual Head StethoscopeDQD · Traditional | Amdia Medical Products | 08/10/1979SE |
| K791335 | NursescopeDQD · Traditional | Amdia Medical Products | 08/10/1979SE |
| K791334 | MultiscopeDQD · Traditional | Amdia Medical Products | 08/10/1979SE |
| K791333 | Bowles StethoscopeDQD · Traditional | Amdia Medical Products | 08/10/1979SE |
| K780738 | Pentax ST-1ADQD · Traditional | Hal-Hen Co., Inc. | 07/17/1978SE |
| K772173 | Stethoscope, ElectronicDQD · Traditional | Affiliated Mailorder Co. Sales, Inc. | 01/24/1978SE |
| K771520 | Esophageal StethoscopeDQD · Traditional | Labarge, Inc. | 09/23/1977SE |
| K771653 | Electronic StethoscopeDQD · Traditional | 3M Company | 09/12/1977SE |
| K771581 | Stethoscope, Nursescope TypeDQD · Traditional | Swartz Medical Equipment | 08/26/1977SE |
| K771506 | StethoscopeDQD · Traditional | Swartz Medical Equipment | 08/26/1977SE |
| K771505 | StethoscopeDQD · Traditional | Swartz Medical Equipment | 08/26/1977SE |
| K771504 | StethoscopeDQD · Traditional | Swartz Medical Equipment | 08/26/1977SE |