FDA 510(k) Applications for Medical Device Product Code "DQD"
(Stethoscope, Electronic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K003723 | 3M COMPANY | 3M LITTMANN | 03/27/2001 |
| K041934 | 3M COMPANY | 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 | 10/15/2004 |
| K083903 | 3M COMPANY | 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 | 07/15/2009 |
| K051790 | 3M COMPANY | 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 | 07/25/2005 |
| K050159 | 3M COMPANY | MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 | 02/22/2005 |
| K103499 | ACTIVE SIGNAL TECHNOLOGIES, INC. | A SCOPE | 03/31/2011 |
| K993623 | ALLEN MEDICAL INSTRUMENTS CORP. | GEMINI E | 06/23/2000 |
| K012304 | AMERICAN DIAGNOSTIC CORP. | ADC 656 ELECTRONIC STETHOSCOPE | 11/01/2001 |
| K060321 | AMERICAN DIAGNOSTIC CORP. | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | 05/15/2006 |
| K162589 | AMERICAN DIAGNOSTIC CORP. | Adscope 658 Electronic Stethoscope | 03/10/2017 |
| K963678 | AMERICAN TELECARE, INC. | CARETONE II | 02/24/1997 |
| K010729 | ANDROMED, INC. | AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A | 10/26/2001 |
| K021389 | ANDROMED, INC. | BIOLOGICAL SOUND MONITOR (BSM) SENSOR | 10/01/2002 |
| K022298 | ANDROMED, INC. | I-STETHOS LINK | 10/01/2002 |
| K001306 | ANDROMED, INC. | STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX | 07/20/2000 |
| K170928 | AUM Cardiovascular, Inc. | CADence System | 08/03/2017 |
| K230823 | AusculThing Oy | AusculThing ACC | 07/12/2023 |
| K183710 | Avicena LLC | Vivio System | 10/04/2019 |
| K991756 | BIO-RESEARCH ASSOCIATES, INC. | 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE | 12/10/1999 |
| K990809 | CADITEC AG | CADISCOPE ELECTRONIC STETHOSCOPE | 06/09/1999 |
| K181882 | Chip Ideas Electronics S.L | eKuore One electronic interface for stethoscope | 03/27/2019 |
| K201742 | Chip Ideas Electronics S.L | eKuore One Wireless Electronic Interface for stethoscope | 11/24/2020 |
| K212013 | Chip Ideas Electronics S.L. | eKuore Pro 4T - REF EP0098 | 11/10/2021 |
| K203007 | Chip Ideas Electronics S.L. | eKuore Pro Series | 10/30/2020 |
| K211779 | Chip Ideas Electronics S.L. | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | 05/26/2022 |
| K220766 | CSD Labs GmbH | eMurmur Heart AI | 05/31/2022 |
| K181988 | CSD Labs GmbH | eMurmur ID | 04/17/2019 |
| K003485 | CYBERCARE TECHNOLOGIES, INC. | CARE PROVIDER STATION ADDITION OF WEIGHT SCALE | 01/11/2001 |
| K002984 | CYBERCARE TECHNOLOGIES, INC. | EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION | 12/18/2000 |
| K961301 | DELPHI CONSULTING GROUP | E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120 | 06/11/1996 |
| K961937 | DELPHI CONSULTING GROUP | SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM | 12/09/1996 |
| K121617 | DIACOUSTIC MEDICAL (PTY) | SENSICARDIAC | 07/27/2012 |
| K110704 | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. | SENSI | 06/24/2011 |
| K131044 | DIACOUSTIC MEDICAL DEVICES (PTY) LTD. | SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION | 09/04/2013 |
| K991714 | DOCTOR'S RESEARCH GROUP, INC. | DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 | 12/10/1999 |
| K002047 | DOCTOR'S RESEARCH GROUP, INC. | DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 | 11/22/2000 |
| K062364 | DONGJIN MEDICAL CO., LTD | I-SCOPE 200 | 12/06/2006 |
| K011898 | E-MED INNOVATIONS, INC. | E-STETH ELECTRONIC STETHOSCOPE | 09/14/2001 |
| K230111 | Eko Devices, Inc. | CORE 500 Digital Stethoscope | 05/26/2023 |
| K200776 | Eko Devices, Inc. | Eko CORE | 04/06/2020 |
| K151319 | Eko Devices, Inc. | Eko Electronic Stethoscope System | 08/28/2015 |
| K170874 | Eko Devices, Inc. | Eko Model E5 System (EME5), Eko DUO | 05/19/2017 |
| K213794 | Eko Devices, Inc. | Eko Murmur Analysis Software (EMAS) | 06/29/2022 |
| K211068 | Entac Medical Inc. | PrevisEA Device | 08/04/2021 |
| K230769 | Entac Medical Inc. | PrevisEA Device | 05/19/2023 |
| K001788 | ERECORDS ENTERPRISES | ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 | 11/03/2000 |
| K021087 | ERECORDS LIMITED | HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE | 10/11/2002 |
| K150782 | GI Logic Inc | AbStats Gateway | 12/14/2015 |
| K961857 | GRAHAM-FIELD, INC. | LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 | 07/03/1996 |
| K031446 | GS TECHNOLOGY CO., LTD. | JABES ELECTRONIC STETHOSCOPE | 10/31/2003 |
| K210736 | GV Concepts | doctorgram Stethoscope DES-I | 07/27/2021 |
| K100531 | HD MEDICAL SERVICES (INDIA) PVT.LTD | VISCOPE, MODEL 100P,100S | 07/21/2010 |
| K201299 | HD Medical, Inc. | HD Steth | 07/10/2020 |
| K050169 | HEALTH & LIFE CO., LTD. | HL 200 ELECTRONIC STETHOSCOPE | 04/05/2005 |
| K212906 | Heartbuds LLC | HeartBuds Electronic Stethoscope | 03/14/2023 |
| K191667 | Hefei Mintti Medical Technology Co., Ltd. China | Electronic Stethoscope | 12/18/2019 |
| K221805 | Heroic Faith International Ltd. | AccurSound Electronic Stethoscope AS-101 | 03/23/2023 |
| K220099 | HomeDiagnostic LLC | eClinic Stethopod | 10/20/2022 |
| K160023 | IMEDIPLUS INC. | Electronic Stethoscope DS301 | 09/30/2016 |
| K173663 | IMEDIPLUS INC. | Electronic Stethoscope DS3011A | 08/17/2018 |
| K182196 | Imediplus, Inc. | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth | 09/11/2018 |
| K103516 | INOVISE MEDICAL, INC. | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 | 02/04/2011 |
| K051450 | INOVISE MEDICAL, INC. | EXTENDED MEASUREMENTS SYSTEM | 11/10/2005 |
| K070550 | KORATEK COMPANY, LTD. | AUSCO ES-3100 | 11/06/2007 |
| K193631 | M3DICINE Pty Ltd. | Stethee Pro 1, Stethee Pro Software System | 10/09/2020 |
| K172296 | M3dicine Pty. Ltd. | Stethee Pro | 10/30/2017 |
| K223166 | Medaica Inc. | Medaica M1 Telehealth Stethoscope | 01/19/2023 |
| K013725 | MEDITRON AS | MEDITRON II THESTERTHOSCOPE SYSTEM | 01/30/2002 |
| K991367 | MEDITRON AS | MEDITRON STETHOSCOPE SYSTEM | 07/19/1999 |
| K961848 | MINNESOTA MINING AND MFG. CO. | 3M LITTMANN ELECTRONIC STETHOSCOPE | 09/26/1997 |
| K202483 | MyHomeDoc Ltd. | MyHomeDoc | 03/23/2021 |
| K082528 | NOBLE ANESTHESIA-AIR, INC. | SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM | 03/06/2009 |
| K223785 | Nonagon Ltd. | N9+ | 04/14/2023 |
| K123148 | PARACE LLC | PARACE MD EKOSCOPE IS100 | 11/19/2013 |
| K062481 | PISHON HIGH TECH CO., LTD. | SERENO ELECTRONIC STETHOSCOPE | 10/16/2006 |
| K082771 | PROTRON TECHNOLOGIES, LLC | PROTRON TECHNOLOGIES, LLC STETHOTRON | 02/27/2009 |
| K131287 | RIJUVEN CORP | CARDIOSLEEVE | 06/24/2013 |
| K034046 | RNK PRODUCTS | RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 | 03/10/2004 |
| K132560 | RNK PRODUCTS, INC. | PCP-USB STETHOSCOPE | 10/11/2013 |
| K102893 | RNK PRODUCTS, INC. | PCP/PC STETHOSCOPE | 01/20/2011 |
| K132405 | RNK PRODUCTS, INC. | PPA/BT-RB STETHOSCOPE | 10/11/2013 |
| K072026 | RNK PRODUCTS, INC. | RNK ELECTRONIC STETHOSCOPE | 10/26/2007 |
| K081032 | RNK PRODUCTS, INC. | TR-USB TELEPHONIC STETHOSCOPE | 06/06/2008 |
| K212709 | Sanolla Ltd. | VoqX Electronic Stethoscope | 03/15/2022 |
| K220470 | Shanghai Hulu Devices Co., Ltd | Smart Wireless Stethoscope | 05/23/2022 |
| K121144 | SHARP CORPORATION | ELECTRONIC STETHOSCOPE | 09/26/2012 |
| K230613 | Smartsound Corporation | SKEEPER | 08/02/2023 |
| K200862 | Sonavi Labs, Inc. | Feelix Stethoscope | 09/14/2020 |
| K023759 | SONOMEDICA | CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER | 05/06/2003 |
| K220466 | Sound Land Corp. | ibiomedi Electronic Stethoscope ES-2020 | 11/03/2022 |
| K222871 | Sparrow Acoustics Inc. | Stethophone v1 | 03/29/2023 |
| K173448 | StethoCloud Pty.Ltd (CliniCloud) | CliniCloud Stethoscope | 01/25/2018 |
| K052283 | STETHOGRAPHICS, INC. | HEART STG SYSTEM AND SOFTWARE | 12/23/2005 |
| K091972 | STETHOSCOPE TECHNOLOGIES, INC | MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 | 09/23/2009 |
| K220196 | StratoScientific | Steth IO Spot | 03/24/2022 |
| K160016 | STRATOSCIENTIFIC, INC. | Steth IO | 07/15/2016 |
| K050097 | TECHTRADE LLC | TECHNO-SCOPE VISUAL STETHOSCOPE | 09/30/2005 |
| K963621 | THERATECHNOLOGIES, INC. | STETHOS | 12/04/1996 |
| K032230 | THINKLABS INC. | RHYTHM DIGITAL ELECTRONIC STETHOSCOPE | 11/26/2003 |
| K963418 | TRANSMEDICA, INC. | TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE | 05/02/1997 |
| K023637 | TYTAN MEDICAL CORP. | TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) | 02/26/2003 |
| K160401 | Tyto Care Ltd. | Tyto Stethoscope | 10/19/2016 |
| K181612 | Tyto Care Ltd. | Tyto Stethoscope (OTC) | 12/17/2018 |
| K042128 | ZARGIS MEDICAL CORP. | MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) | 09/08/2004 |
| K090493 | ZARGIS MEDICAL CORP. | SIGNAL | 08/07/2009 |
| K031517 | ZARGIS MEDICAL CORP. | ZARGIS ACOUSTIC CARDIOSCAN | 05/26/2004 |
| K060197 | ZARGIS MEDICAL CORP. | ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 | 03/29/2006 |
| K083309 | ZARGIS MEDICAL CORP. | ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 | 02/13/2009 |
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