FDA Product Code
FDA Product Code DQD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1875
510(k) Clearances — 156 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 | Traditional | PDF ↗ |
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | 2026-07-23 | Traditional | PDF ↗ |
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | 2026-05-22 | Traditional | PDF ↗ |
| K252089 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | 2026-03-12 | Traditional | PDF ↗ |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K252284 | eMurmur Heart AI | Csd Labs | 2025-12-19 | Traditional | PDF ↗ |
| K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025-09-12 | Special | PDF ↗ |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | 2025-08-12 | Traditional | PDF ↗ |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | 2024-11-25 | Traditional | PDF ↗ |
| K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024-09-19 | Traditional | PDF ↗ |
| K233313 | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | 2024-04-10 | Traditional | PDF ↗ |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | 2024-03-28 | Traditional | PDF ↗ |
| K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023-10-12 | Traditional | PDF ↗ |
| K230613 | SKEEPER | Smartsound Corporation | 2023-08-02 | Traditional | PDF ↗ |
| K230823 | AusculThing ACC | Ausculthing OY | 2023-07-12 | Traditional | PDF ↗ |
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | 2023-05-26 | Traditional | PDF ↗ |
| K230769 | PrevisEA Device | Entac Medical, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| K223785 | N9+ | Nonagon , Ltd. | 2023-04-14 | Traditional | PDF ↗ |
| K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | 2023-03-29 | Traditional | PDF ↗ |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | 2023-03-23 | Traditional | PDF ↗ |
| K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | 2023-03-14 | Traditional | PDF ↗ |
| K223166 | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | 2023-01-19 | Traditional | PDF ↗ |
| K220466 | ibiomedi Electronic Stethoscope ES-2020 | Sound Land Corp. | 2022-11-03 | Traditional | PDF ↗ |
| K220099 | eClinic Stethopod | Homediagnostic, LLC | 2022-10-20 | Traditional | PDF ↗ |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022-06-29 | Traditional | PDF ↗ |
| K220766 | eMurmur Heart AI | Csd Labs GmbH | 2022-05-31 | Special | PDF ↗ |
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | Chip Ideas Electronics S.L. | 2022-05-26 | Traditional | PDF ↗ |
| K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | 2022-05-23 | Traditional | PDF ↗ |
| K220196 | Steth IO Spot | Stratoscientific | 2022-03-24 | Traditional | PDF ↗ |
| K212709 | VoqX Electronic Stethoscope | Sanolla , Ltd. | 2022-03-15 | Traditional | PDF ↗ |
| K212013 | eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. | 2021-11-10 | Special | PDF ↗ |
| K211068 | PrevisEA Device | Entac Medical, Inc. | 2021-08-04 | Traditional | PDF ↗ |
| K210736 | doctorgram Stethoscope DES-I | Gv Concepts | 2021-07-27 | Traditional | PDF ↗ |
| K202483 | MyHomeDoc | Myhomedoc , Ltd. | 2021-03-23 | Traditional | PDF ↗ |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | Chip Ideas Electronics S.L. | 2020-11-24 | Traditional | PDF ↗ |
| K203007 | eKuore Pro Series | Chip Ideas Electronics S.L. | 2020-10-30 | Traditional | PDF ↗ |
| K193631 | Stethee Pro 1, Stethee Pro Software System | M3Dicine Pty , Ltd. | 2020-10-09 | Traditional | PDF ↗ |
| K200862 | Feelix Stethoscope | Sonavi Labs, Inc. | 2020-09-14 | Traditional | PDF ↗ |
| K201299 | HD Steth | Hd Medical, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K200776 | Eko CORE | Eko Devices, Inc. | 2020-04-06 | Traditional | PDF ↗ |
| K191667 | Electronic Stethoscope | Hefei Mintti Medical Technology Co., Ltd. China | 2019-12-18 | Traditional | PDF ↗ |
| K183710 | Vivio System | Avicena, LLC | 2019-10-04 | Traditional | PDF ↗ |
| K181988 | eMurmur ID | Csd Labs GmbH | 2019-04-17 | Traditional | PDF ↗ |
| K181882 | eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. | 2019-03-27 | Traditional | PDF ↗ |
| K181612 | Tyto Stethoscope (OTC) | Tyto Care , Ltd. | 2018-12-17 | Traditional | PDF ↗ |
| K182196 | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth | Imediplus, Inc. | 2018-09-11 | Traditional | PDF ↗ |
| K173663 | Electronic Stethoscope DS3011A | Imediplus, Inc. | 2018-08-17 | Abbreviated | PDF ↗ |
| K173448 | CliniCloud Stethoscope | Stethocloud Pty.Ltd (Clinicloud) | 2018-01-25 | Traditional | PDF ↗ |
| K172296 | Stethee Pro | M3Dicine Pty , Ltd. | 2017-10-30 | Traditional | PDF ↗ |
| K170928 | CADence System | Aum Cardiovascular, Inc. | 2017-08-03 | Traditional | PDF ↗ |
| K170874 | Eko Model E5 System (EME5), Eko DUO | Eko Devices, Inc. | 2017-05-19 | Traditional | PDF ↗ |
| K162589 | Adscope 658 Electronic Stethoscope | American Diagnostic Corp. | 2017-03-10 | Traditional | PDF ↗ |
| K160401 | Tyto Stethoscope | Tyto Care , Ltd. | 2016-10-19 | Traditional | PDF ↗ |
| K160023 | Electronic Stethoscope DS301 | Imediplus, Inc. | 2016-09-30 | Traditional | PDF ↗ |
| K160016 | Steth IO | Stratoscientific, Inc. | 2016-07-15 | Traditional | PDF ↗ |
| K150782 | AbStats Gateway | Gi Logic, Inc. | 2015-12-14 | Traditional | PDF ↗ |
| K151319 | Eko Electronic Stethoscope System | Eko Devices, Inc. | 2015-08-28 | Traditional | PDF ↗ |
| K123148 | PARACE MD EKOSCOPE IS100 | Parace, LLC | 2013-11-19 | Traditional | PDF ↗ |
| K132560 | PCP-USB STETHOSCOPE | Rnk Products, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K132405 | PPA/BT-RB STETHOSCOPE | Rnk Products, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K131044 | SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION | Diacoustic Medical Devices (Pty) , Ltd. | 2013-09-04 | Traditional | PDF ↗ |
| K131287 | CARDIOSLEEVE | Rijuven Corp | 2013-06-24 | Traditional | PDF ↗ |
| K121144 | ELECTRONIC STETHOSCOPE | Sharp Corporation | 2012-09-26 | Traditional | PDF ↗ |
| K121617 | SENSICARDIAC | Diacoustic Medical (Pty) | 2012-07-27 | Traditional | PDF ↗ |
| K110704 | SENSI | Diacoustic Medical Devices (Pty) , Ltd. | 2011-06-24 | Traditional | PDF ↗ |
| K103499 | A SCOPE | Active Signal Technologies, Inc. | 2011-03-31 | Traditional | PDF ↗ |
| K103516 | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 | Inovise Medical, Inc. | 2011-02-04 | Traditional | PDF ↗ |
| K102893 | PCP/PC STETHOSCOPE | Rnk Products, Inc. | 2011-01-20 | Traditional | PDF ↗ |
| K100531 | VISCOPE, MODEL 100P,100S | Hd Medical Services (India) Pvt.Ltd | 2010-07-21 | Traditional | PDF ↗ |
| K091972 | MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 | Stethoscope Technologies, Inc. | 2009-09-23 | Traditional | PDF ↗ |
| K090493 | SIGNAL | Zargis Medical Corp. | 2009-08-07 | Traditional | PDF ↗ |
| K083903 | 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 | 3M Company | 2009-07-15 | Traditional | PDF ↗ |
| K082528 | SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM | Noble Anesthesia-Air, Inc. | 2009-03-06 | Traditional | PDF ↗ |
| K082771 | PROTRON TECHNOLOGIES, LLC STETHOTRON | Protron Technologies, LLC | 2009-02-27 | Traditional | PDF ↗ |
| K083309 | ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 | Zargis Medical Corp. | 2009-02-13 | Special | PDF ↗ |
| K081032 | TR-USB TELEPHONIC STETHOSCOPE | Rnk Products, Inc. | 2008-06-06 | Traditional | PDF ↗ |
| K070550 | AUSCO ES-3100 | Koratek Company, Ltd. | 2007-11-06 | Traditional | PDF ↗ |
| K072026 | RNK ELECTRONIC STETHOSCOPE | Rnk Products, Inc. | 2007-10-26 | Traditional | PDF ↗ |
| K062364 | I-SCOPE 200 | Dongjin Medical Co., Ltd. | 2006-12-06 | Traditional | PDF ↗ |
| K062481 | SERENO ELECTRONIC STETHOSCOPE | Pishon High Tech Co., Ltd. | 2006-10-16 | Traditional | PDF ↗ |
| K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | American Diagnostic Corp. | 2006-05-15 | Traditional | PDF ↗ |
| K060197 | ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 | Zargis Medical Corp. | 2006-03-29 | Special | PDF ↗ |
| K052283 | HEART STG SYSTEM AND SOFTWARE | Stethographics, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K051450 | EXTENDED MEASUREMENTS SYSTEM | Inovise Medical, Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K050097 | TECHNO-SCOPE VISUAL STETHOSCOPE | Techtrade, LLC | 2005-09-30 | Traditional | PDF ↗ |
| K051790 | 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 | 3M Company | 2005-07-25 | Special | PDF ↗ |
| K050169 | HL 200 ELECTRONIC STETHOSCOPE | Health & Life Co., Ltd. | 2005-04-05 | Traditional | PDF ↗ |
| K050159 | MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 | 3M Company | 2005-02-22 | Special | PDF ↗ |
| K041934 | 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 | 3M Company | 2004-10-15 | Traditional | PDF ↗ |
| K042128 | MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) | Zargis Medical Corp. | 2004-09-08 | Special | PDF ↗ |
| K031517 | ZARGIS ACOUSTIC CARDIOSCAN | Zargis Medical Corp. | 2004-05-26 | Traditional | PDF ↗ |
| K034046 | RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 | Rnk Products | 2004-03-10 | Traditional | PDF ↗ |
| K032230 | RHYTHM DIGITAL ELECTRONIC STETHOSCOPE | Thinklabs, Inc. | 2003-11-26 | Traditional | PDF ↗ |
| K031446 | JABES ELECTRONIC STETHOSCOPE | Gs Technology Co., Ltd. | 2003-10-31 | Traditional | PDF ↗ |
| K023759 | CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER | Sonomedica | 2003-05-06 | Traditional | PDF ↗ |
| K023637 | TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) | Tytan Medical Corp. | 2003-02-26 | Traditional | PDF ↗ |
| K021087 | HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE | Erecords Limited | 2002-10-11 | Abbreviated | PDF ↗ |
| K022298 | I-STETHOS LINK | Andromed, Inc. | 2002-10-01 | Abbreviated | PDF ↗ |
| K021389 | BIOLOGICAL SOUND MONITOR (BSM) SENSOR | Andromed, Inc. | 2002-10-01 | Abbreviated | PDF ↗ |
| K013725 | MEDITRON II THESTERTHOSCOPE SYSTEM | Meditron AS | 2002-01-30 | Traditional | PDF ↗ |
Product code DQD · Class II · Cardiovascular. Data: openFDA.