Stethoscope, Electronic

FDA product code DQD · 154 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1875
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-26 – 2026-07-31

DQD 2026-07-31

Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)

Applicant Shanghai Hulu Devices Co., Ltd.

K number K261494

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DQD 2026-07-23

CORE 300 Digital Stethoscope

Applicant Eko Health, Inc.

K number K261694

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DQD 2026-05-22

AiSteth®

Applicant Ai Health Highway India Pvt., Ltd.

K number K252915

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DQD 2026-03-12

Tyto Stethoscope (G3)

Applicant Tyto Care , Ltd.

K number K252089

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DQD 2026-02-06

Kneevoice Cartilage Evaluation System (750-3600-001)

Applicant Kneevoice, Inc.

K number K252076

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DQD 2025-12-19

eMurmur Heart AI

Applicant Csd Labs

K number K252284

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DQD 2025-09-12

Stethophone Pro

Applicant Sparrow Acoustics, Inc.

K number K252595

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DQD 2025-08-12

Eko Foundation Analysis Software with Transformers (EFAST)

Applicant Eko Health, Inc.

K number K251494

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DQD 2024-11-25

AccurSound Electronic Stethoscope (AS101)

Applicant Heroic Faith International , Ltd.

K number K242971

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DQD 2024-09-19

Stethophone

Applicant Sparrow Acoustics, Inc.

K number K240901

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DQD 2024-04-10

Keikku Electronic stethoscope

Applicant Lapsi Health Holding B.V.

K number K233313

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DQD 2024-03-28

CORE 500 Digital Stethoscope

Applicant Eko Health, Inc.

K number K233609

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DQD 2023-10-12

Stethophone

Applicant Sparrow Acoustics, Inc.

K number K231551

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DQD 2023-08-02

SKEEPER

Applicant Smartsound Corporation

K number K230613

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DQD 2023-07-12

AusculThing ACC

Applicant Ausculthing OY

K number K230823

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DQD 2023-05-26

CORE 500 Digital Stethoscope

Applicant Eko Devices, Inc.

K number K230111

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DQD 2023-05-19

PrevisEA Device

Applicant Entac Medical, Inc.

K number K230769

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DQD 2023-04-14

N9+

Applicant Nonagon , Ltd.

K number K223785

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DQD 2023-03-29

Stethophone v1

Applicant Sparrow Acoustics, Inc.

K number K222871

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DQD 2023-03-23

AccurSound Electronic Stethoscope AS-101

Applicant Heroic Faith International , Ltd.

K number K221805

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DQD 2023-03-14

HeartBuds Electronic Stethoscope

Applicant Heartbuds, LLC

K number K212906

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DQD 2023-01-19

Medaica M1 Telehealth Stethoscope

Applicant Medaica, Inc.

K number K223166

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DQD 2022-11-03

ibiomedi Electronic Stethoscope ES-2020

Applicant Sound Land Corp.

K number K220466

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DQD 2022-10-20

eClinic Stethopod

Applicant Homediagnostic, LLC

K number K220099

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DQD 2022-06-29

Eko Murmur Analysis Software (EMAS)

Applicant Eko Devices, Inc.

K number K213794

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DQD 2022-05-31

eMurmur Heart AI

Applicant Csd Labs GmbH

K number K220766

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DQD 2022-05-26

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

Applicant Chip Ideas Electronics S.L.

K number K211779

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DQD 2022-05-23

Smart Wireless Stethoscope

Applicant Shanghai Hulu Devices Co., Ltd.

K number K220470

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DQD 2022-03-24

Steth IO Spot

Applicant Stratoscientific

K number K220196

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DQD 2022-03-15

VoqX Electronic Stethoscope

Applicant Sanolla , Ltd.

K number K212709

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DQD 2021-11-10

eKuore Pro 4T - REF EP0098

Applicant Chip Ideas Electronics S.L.

K number K212013

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DQD 2021-08-04

PrevisEA Device

Applicant Entac Medical, Inc.

K number K211068

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DQD 2021-07-27

doctorgram Stethoscope DES-I

Applicant Gv Concepts

K number K210736

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DQD 2021-03-23

MyHomeDoc

Applicant Myhomedoc , Ltd.

K number K202483

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DQD 2020-11-24

eKuore One Wireless Electronic Interface for stethoscope

Applicant Chip Ideas Electronics S.L.

K number K201742

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DQD 2020-10-30

eKuore Pro Series

Applicant Chip Ideas Electronics S.L.

K number K203007

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DQD 2020-10-09

Stethee Pro 1, Stethee Pro Software System

Applicant M3Dicine Pty , Ltd.

K number K193631

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DQD 2020-09-14

Feelix Stethoscope

Applicant Sonavi Labs, Inc.

K number K200862

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DQD 2020-07-10

HD Steth

Applicant Hd Medical, Inc.

K number K201299

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DQD 2020-04-06

Eko CORE

Applicant Eko Devices, Inc.

K number K200776

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DQD 2019-12-18

Electronic Stethoscope

Applicant Hefei Mintti Medical Technology Co., Ltd. China

K number K191667

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DQD 2019-10-04

Vivio System

Applicant Avicena, LLC

K number K183710

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DQD 2019-04-17

eMurmur ID

Applicant Csd Labs GmbH

K number K181988

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DQD 2019-03-27

eKuore One electronic interface for stethoscope

Applicant Chip Ideas Electronics S.L.

K number K181882

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DQD 2018-12-17

Tyto Stethoscope (OTC)

Applicant Tyto Care , Ltd.

K number K181612

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DQD 2018-09-11

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

Applicant Imediplus, Inc.

K number K182196

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DQD 2018-08-17

Electronic Stethoscope DS3011A

Applicant Imediplus, Inc.

K number K173663

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DQD 2018-01-25

CliniCloud Stethoscope

Applicant Stethocloud Pty.Ltd (Clinicloud)

K number K173448

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DQD 2017-10-30

Stethee Pro

Applicant M3Dicine Pty , Ltd.

K number K172296

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DQD 2017-08-03

CADence System

Applicant Aum Cardiovascular, Inc.

K number K170928

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DQD 2017-05-19

Eko Model E5 System (EME5), Eko DUO

Applicant Eko Devices, Inc.

K number K170874

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DQD 2017-03-10

Adscope 658 Electronic Stethoscope

Applicant American Diagnostic Corp.

K number K162589

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DQD 2016-10-19

Tyto Stethoscope

Applicant Tyto Care , Ltd.

K number K160401

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DQD 2016-09-30

Electronic Stethoscope DS301

Applicant Imediplus, Inc.

K number K160023

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DQD 2016-07-15

Steth IO

Applicant Stratoscientific, Inc.

K number K160016

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DQD 2013-11-19

PARACE MD EKOSCOPE IS100

Applicant Parace, LLC

K number K123148

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DQD 2013-10-11

PCP-USB STETHOSCOPE

Applicant Rnk Products, Inc.

K number K132560

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DQD 2013-10-11

PPA/BT-RB STETHOSCOPE

Applicant Rnk Products, Inc.

K number K132405

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DQD 2013-09-04

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

Applicant Diacoustic Medical Devices (Pty) , Ltd.

K number K131044

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DQD 2013-06-24

CARDIOSLEEVE

Applicant Rijuven Corp

K number K131287

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DQD 2012-09-26

ELECTRONIC STETHOSCOPE

Applicant Sharp Corporation

K number K121144

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DQD 2012-07-27

SENSICARDIAC

Applicant Diacoustic Medical (Pty)

K number K121617

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DQD 2011-06-24

SENSI

Applicant Diacoustic Medical Devices (Pty) , Ltd.

K number K110704

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DQD 2011-03-31

A SCOPE

Applicant Active Signal Technologies, Inc.

K number K103499

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DQD 2011-02-04

AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0

Applicant Inovise Medical, Inc.

K number K103516

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DQD 2011-01-20

PCP/PC STETHOSCOPE

Applicant Rnk Products, Inc.

K number K102893

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DQD 2010-07-21

VISCOPE, MODEL 100P,100S

Applicant Hd Medical Services (India) Pvt.Ltd

K number K100531

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DQD 2009-09-23

MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01

Applicant Stethoscope Technologies, Inc.

K number K091972

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DQD 2009-08-07

SIGNAL

Applicant Zargis Medical Corp.

K number K090493

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DQD 2009-07-15

3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200

Applicant 3M Company

K number K083903

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DQD 2009-03-06

SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM

Applicant Noble Anesthesia-Air, Inc.

K number K082528

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DQD 2009-02-27

PROTRON TECHNOLOGIES, LLC STETHOTRON

Applicant Protron Technologies, LLC

K number K082771

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DQD 2009-02-13

ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33

Applicant Zargis Medical Corp.

K number K083309

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DQD 2008-06-06

TR-USB TELEPHONIC STETHOSCOPE

Applicant Rnk Products, Inc.

K number K081032

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DQD 2007-11-06

AUSCO ES-3100

Applicant Koratek Company, Ltd.

K number K070550

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DQD 2007-10-26

RNK ELECTRONIC STETHOSCOPE

Applicant Rnk Products, Inc.

K number K072026

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DQD 2006-12-06

I-SCOPE 200

Applicant Dongjin Medical Co., Ltd.

K number K062364

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DQD 2006-10-16

SERENO ELECTRONIC STETHOSCOPE

Applicant Pishon High Tech Co., Ltd.

K number K062481

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DQD 2006-05-15

ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK

Applicant American Diagnostic Corp.

K number K060321

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DQD 2006-03-29

ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28

Applicant Zargis Medical Corp.

K number K060197

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DQD 2005-12-23

HEART STG SYSTEM AND SOFTWARE

Applicant Stethographics, Inc.

K number K052283

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DQD 2005-11-10

EXTENDED MEASUREMENTS SYSTEM

Applicant Inovise Medical, Inc.

K number K051450

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DQD 2005-09-30

TECHNO-SCOPE VISUAL STETHOSCOPE

Applicant Techtrade, LLC

K number K050097

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DQD 2005-07-25

3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100

Applicant 3M Company

K number K051790

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DQD 2005-04-05

HL 200 ELECTRONIC STETHOSCOPE

Applicant Health & Life Co., Ltd.

K number K050169

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DQD 2005-02-22

MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000

Applicant 3M Company

K number K050159

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DQD 2004-10-15

3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000

Applicant 3M Company

K number K041934

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DQD 2004-09-08

MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)

Applicant Zargis Medical Corp.

K number K042128

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DQD 2004-05-26

ZARGIS ACOUSTIC CARDIOSCAN

Applicant Zargis Medical Corp.

K number K031517

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DQD 2004-03-10

RNK TELEPHONIC STETHOSCOPE, MODEL TR-1

Applicant Rnk Products

K number K034046

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DQD 2003-11-26

RHYTHM DIGITAL ELECTRONIC STETHOSCOPE

Applicant Thinklabs, Inc.

K number K032230

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DQD 2003-10-31

JABES ELECTRONIC STETHOSCOPE

Applicant Gs Technology Co., Ltd.

K number K031446

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DQD 2003-05-06

CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER

Applicant Sonomedica

K number K023759

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DQD 2003-02-26

TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)

Applicant Tytan Medical Corp.

K number K023637

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DQD 2002-10-11

HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE

Applicant Erecords Limited

K number K021087

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DQD 2002-10-01

I-STETHOS LINK

Applicant Andromed, Inc.

K number K022298

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DQD 2002-10-01

BIOLOGICAL SOUND MONITOR (BSM) SENSOR

Applicant Andromed, Inc.

K number K021389

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DQD 2002-01-30

MEDITRON II THESTERTHOSCOPE SYSTEM

Applicant Meditron AS

K number K013725

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DQD 2001-11-01

ADC 656 ELECTRONIC STETHOSCOPE

Applicant American Diagnostic Corp.

K number K012304

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DQD 2001-10-26

AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A

Applicant Andromed, Inc.

K number K010729

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