Product Code: DQD FDA class 2 21 CFR 870.1875

Stethoscope, Electronic

Cardiovascular

The Electronic Stethoscope is a cardiovascular auscultation device that amplifies and may digitally process body sounds, particularly heart and lung sounds, to assist clinicians in diagnosis. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQD and it is regulated under 21 CFR 870.1875 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

148

FEI Numbers

Registration Numbers

Unique Applicants

102

Years Active

Basic Information

Product Code: DQD
Device Class: FDA class 2
Regulation Number: 870.1875
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 148 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242971	AccurSound Electronic Stethoscope (AS101)	Nov 25, 2024	Substantially Equivalent	Heroic Faith International Ltd.
K240901	Stethophone	Sep 19, 2024	Substantially Equivalent	Sparrow Acoustics Inc.
K233313	Keikku Electronic stethoscope	Apr 10, 2024	Substantially Equivalent	Lapsi Health Holding B.V
K233609	CORE 500 Digital Stethoscope	Mar 28, 2024	Substantially Equivalent	Eko Health, Inc.
K231551	Stethophone	Oct 12, 2023	Substantially Equivalent	Sparrow Acoustics Inc.
K230613	SKEEPER	Aug 02, 2023	Substantially Equivalent	Smartsound Corporation
K230823	AusculThing ACC	Jul 12, 2023	Substantially Equivalent	AusculThing Oy
K230111	CORE 500 Digital Stethoscope	May 26, 2023	Substantially Equivalent	Eko Devices, Inc.
K230769	PrevisEA Device	May 19, 2023	Substantially Equivalent	Entac Medical Inc.
K223785	N9+	Apr 14, 2023	Substantially Equivalent	Nonagon Ltd.
K222871	Stethophone v1	Mar 29, 2023	Substantially Equivalent	Sparrow Acoustics Inc.
K221805	AccurSound Electronic Stethoscope AS-101	Mar 23, 2023	Substantially Equivalent	Heroic Faith International Ltd.
K212906	HeartBuds Electronic Stethoscope	Mar 14, 2023	Substantially Equivalent	Heartbuds LLC
K223166	Medaica M1 Telehealth Stethoscope	Jan 19, 2023	Substantially Equivalent	Medaica Inc.
K220466	ibiomedi Electronic Stethoscope ES-2020	Nov 03, 2022	Substantially Equivalent	Sound Land Corp.
K220099	eClinic Stethopod	Oct 20, 2022	Substantially Equivalent	HomeDiagnostic LLC
K213794	Eko Murmur Analysis Software (EMAS)	Jun 29, 2022	Substantially Equivalent	Eko Devices, Inc.
K220766	eMurmur Heart AI	May 31, 2022	Substantially Equivalent	CSD Labs GmbH
K211779	ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.	May 26, 2022	Substantially Equivalent	Chip Ideas Electronics S.L.
K220470	Smart Wireless Stethoscope	May 23, 2022	Substantially Equivalent	Shanghai Hulu Devices Co., Ltd
K220196	Steth IO Spot	Mar 24, 2022	Substantially Equivalent	StratoScientific
K212709	VoqX Electronic Stethoscope	Mar 15, 2022	Substantially Equivalent	Sanolla Ltd.
K212013	eKuore Pro 4T - REF EP0098	Nov 10, 2021	Substantially Equivalent	Chip Ideas Electronics S.L.
K211068	PrevisEA Device	Aug 04, 2021	Substantially Equivalent	Entac Medical Inc.
K210736	doctorgram Stethoscope DES-I	Jul 27, 2021	Substantially Equivalent	GV Concepts
K202483	MyHomeDoc	Mar 23, 2021	Substantially Equivalent	MyHomeDoc Ltd.
K201742	eKuore One Wireless Electronic Interface for stethoscope	Nov 24, 2020	Substantially Equivalent	Chip Ideas Electronics S.L
K203007	eKuore Pro Series	Oct 30, 2020	Substantially Equivalent	Chip Ideas Electronics S.L.
K193631	Stethee Pro 1, Stethee Pro Software System	Oct 09, 2020	Substantially Equivalent	M3DICINE Pty Ltd.
K200862	Feelix Stethoscope	Sep 14, 2020	Substantially Equivalent	Sonavi Labs, Inc.
K201299	HD Steth	Jul 10, 2020	Substantially Equivalent	HD Medical, Inc.
K200776	Eko CORE	Apr 06, 2020	Substantially Equivalent	Eko Devices, Inc.
K191667	Electronic Stethoscope	Dec 18, 2019	Substantially Equivalent	Hefei Mintti Medical Technology Co., Ltd. China
K183710	Vivio System	Oct 04, 2019	Substantially Equivalent	Avicena LLC
K181988	eMurmur ID	Apr 17, 2019	Substantially Equivalent	CSD Labs GmbH
K181882	eKuore One electronic interface for stethoscope	Mar 27, 2019	Substantially Equivalent	Chip Ideas Electronics S.L
K181612	Tyto Stethoscope (OTC)	Dec 17, 2018	Substantially Equivalent	Tyto Care Ltd.
K182196	Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth	Sep 11, 2018	Substantially Equivalent	Imediplus, Inc.
K173663	Electronic Stethoscope DS3011A	Aug 17, 2018	Substantially Equivalent	IMEDIPLUS INC.
K173448	CliniCloud Stethoscope	Jan 25, 2018	Substantially Equivalent	StethoCloud Pty.Ltd (CliniCloud)
K172296	Stethee Pro	Oct 30, 2017	Substantially Equivalent	M3dicine Pty. Ltd.
K170928	CADence System	Aug 03, 2017	Substantially Equivalent	AUM Cardiovascular, Inc.
K170874	Eko Model E5 System (EME5), Eko DUO	May 19, 2017	Substantially Equivalent	Eko Devices, Inc.
K162589	Adscope 658 Electronic Stethoscope	Mar 10, 2017	Substantially Equivalent	AMERICAN DIAGNOSTIC CORP.
K160401	Tyto Stethoscope	Oct 19, 2016	Substantially Equivalent	Tyto Care Ltd.
K160023	Electronic Stethoscope DS301	Sep 30, 2016	Substantially Equivalent	IMEDIPLUS INC.
K160016	Steth IO	Jul 15, 2016	Substantially Equivalent	STRATOSCIENTIFIC, INC.
K150782	AbStats Gateway	Dec 14, 2015	Substantially Equivalent	GI Logic Inc
K151319	Eko Electronic Stethoscope System	Aug 28, 2015	Substantially Equivalent	Eko Devices, Inc.
K123148	PARACE MD EKOSCOPE IS100	Nov 19, 2013	Substantially Equivalent	PARACE LLC
K132560	PCP-USB STETHOSCOPE	Oct 11, 2013	Substantially Equivalent	RNK PRODUCTS, INC.
K132405	PPA/BT-RB STETHOSCOPE	Oct 11, 2013	Substantially Equivalent	RNK PRODUCTS, INC.
K131044	SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION	Sep 04, 2013	Substantially Equivalent	DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
K131287	CARDIOSLEEVE	Jun 24, 2013	Substantially Equivalent	RIJUVEN CORP
K121144	ELECTRONIC STETHOSCOPE	Sep 26, 2012	Substantially Equivalent	SHARP CORPORATION
K121617	SENSICARDIAC	Jul 27, 2012	Substantially Equivalent	DIACOUSTIC MEDICAL (PTY)
K110704	SENSI	Jun 24, 2011	Substantially Equivalent	DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
K103499	A SCOPE	Mar 31, 2011	Substantially Equivalent	ACTIVE SIGNAL TECHNOLOGIES, INC.
K103516	AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0	Feb 04, 2011	Substantially Equivalent	INOVISE MEDICAL, INC.
K102893	PCP/PC STETHOSCOPE	Jan 20, 2011	Substantially Equivalent	RNK PRODUCTS, INC.
K100531	VISCOPE, MODEL 100P,100S	Jul 21, 2010	Substantially Equivalent	HD MEDICAL SERVICES (INDIA) PVT.LTD
K091972	MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01	Sep 23, 2009	Substantially Equivalent	STETHOSCOPE TECHNOLOGIES, INC
K090493	SIGNAL	Aug 07, 2009	Substantially Equivalent	ZARGIS MEDICAL CORP.
K083903	3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200	Jul 15, 2009	Substantially Equivalent	3M COMPANY
K082528	SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM	Mar 06, 2009	Substantially Equivalent	NOBLE ANESTHESIA-AIR, INC.
K082771	PROTRON TECHNOLOGIES, LLC STETHOTRON	Feb 27, 2009	Substantially Equivalent	PROTRON TECHNOLOGIES, LLC
K083309	ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33	Feb 13, 2009	Substantially Equivalent	ZARGIS MEDICAL CORP.
K081032	TR-USB TELEPHONIC STETHOSCOPE	Jun 06, 2008	Substantially Equivalent	RNK PRODUCTS, INC.
K070550	AUSCO ES-3100	Nov 06, 2007	Substantially Equivalent	KORATEK COMPANY, LTD.
K072026	RNK ELECTRONIC STETHOSCOPE	Oct 26, 2007	Substantially Equivalent	RNK PRODUCTS, INC.
K062364	I-SCOPE 200	Dec 06, 2006	Substantially Equivalent	DONGJIN MEDICAL CO., LTD
K062481	SERENO ELECTRONIC STETHOSCOPE	Oct 16, 2006	Substantially Equivalent	PISHON HIGH TECH CO., LTD.
K060321	ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK	May 15, 2006	Substantially Equivalent	AMERICAN DIAGNOSTIC CORP.
K060197	ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28	Mar 29, 2006	Substantially Equivalent	ZARGIS MEDICAL CORP.
K052283	HEART STG SYSTEM AND SOFTWARE	Dec 23, 2005	Substantially Equivalent	STETHOGRAPHICS, INC.
K051450	EXTENDED MEASUREMENTS SYSTEM	Nov 10, 2005	Substantially Equivalent	INOVISE MEDICAL, INC.
K050097	TECHNO-SCOPE VISUAL STETHOSCOPE	Sep 30, 2005	Substantially Equivalent	TECHTRADE LLC
K051790	3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100	Jul 25, 2005	Substantially Equivalent	3M COMPANY
K050169	HL 200 ELECTRONIC STETHOSCOPE	Apr 05, 2005	Substantially Equivalent	HEALTH & LIFE CO., LTD.
K050159	MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000	Feb 22, 2005	Substantially Equivalent	3M COMPANY
K041934	3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000	Oct 15, 2004	Substantially Equivalent	3M COMPANY
K042128	MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)	Sep 08, 2004	Substantially Equivalent	ZARGIS MEDICAL CORP.
K031517	ZARGIS ACOUSTIC CARDIOSCAN	May 26, 2004	Substantially Equivalent	ZARGIS MEDICAL CORP.
K034046	RNK TELEPHONIC STETHOSCOPE, MODEL TR-1	Mar 10, 2004	Substantially Equivalent	RNK PRODUCTS
K032230	RHYTHM DIGITAL ELECTRONIC STETHOSCOPE	Nov 26, 2003	Substantially Equivalent	THINKLABS INC.
K031446	JABES ELECTRONIC STETHOSCOPE	Oct 31, 2003	Substantially Equivalent	GS TECHNOLOGY CO., LTD.
K023759	CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER	May 06, 2003	Substantially Equivalent	SONOMEDICA
K023637	TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)	Feb 26, 2003	Substantially Equivalent	TYTAN MEDICAL CORP.
K021087	HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE	Oct 11, 2002	Substantially Equivalent	ERECORDS LIMITED
K022298	I-STETHOS LINK	Oct 01, 2002	Substantially Equivalent	ANDROMED, INC.
K021389	BIOLOGICAL SOUND MONITOR (BSM) SENSOR	Oct 01, 2002	Substantially Equivalent	ANDROMED, INC.
K013725	MEDITRON II THESTERTHOSCOPE SYSTEM	Jan 30, 2002	Substantially Equivalent	MEDITRON AS
K012304	ADC 656 ELECTRONIC STETHOSCOPE	Nov 01, 2001	Substantially Equivalent	AMERICAN DIAGNOSTIC CORP.
K010729	AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A	Oct 26, 2001	Substantially Equivalent	ANDROMED, INC.
K011898	E-STETH ELECTRONIC STETHOSCOPE	Sep 14, 2001	Substantially Equivalent	E-MED INNOVATIONS, INC.
K003723	3M LITTMANN	Mar 27, 2001	Substantially Equivalent	3M COMPANY
K003485	CARE PROVIDER STATION ADDITION OF WEIGHT SCALE	Jan 11, 2001	Substantially Equivalent	CYBERCARE TECHNOLOGIES, INC.
K002984	EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION	Dec 18, 2000	Substantially Equivalent	CYBERCARE TECHNOLOGIES, INC.
K002047	DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2	Nov 22, 2000	Substantially Equivalent	DOCTOR'S RESEARCH GROUP, INC.
K001788	ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200	Nov 03, 2000	Substantially Equivalent	ERECORDS ENTERPRISES
K001306	STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX	Jul 20, 2000	Substantially Equivalent	ANDROMED, INC.
K993623	GEMINI E	Jun 23, 2000	Substantially Equivalent	ALLEN MEDICAL INSTRUMENTS CORP.
K991756	3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE	Dec 10, 1999	Substantially Equivalent	BIO-RESEARCH ASSOCIATES, INC.
K991714	DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00	Dec 10, 1999	Substantially Equivalent	DOCTOR'S RESEARCH GROUP, INC.
K991367	MEDITRON STETHOSCOPE SYSTEM	Jul 19, 1999	Substantially Equivalent	MEDITRON AS
K990809	CADISCOPE ELECTRONIC STETHOSCOPE	Jun 09, 1999	Substantially Equivalent	CADITEC AG
K961848	3M LITTMANN ELECTRONIC STETHOSCOPE	Sep 26, 1997	Substantially Equivalent	MINNESOTA MINING AND MFG. CO.
K963418	TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE	May 02, 1997	Substantially Equivalent	TRANSMEDICA, INC.
K963678	CARETONE II	Feb 24, 1997	Substantially Equivalent	AMERICAN TELECARE, INC.
K961937	SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM	Dec 09, 1996	Substantially Equivalent	DELPHI CONSULTING GROUP
K963621	STETHOS	Dec 04, 1996	Substantially Equivalent	THERATECHNOLOGIES, INC.
K961857	LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060	Jul 03, 1996	Substantially Equivalent	GRAHAM-FIELD, INC.
K961301	E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120	Jun 11, 1996	Substantially Equivalent	DELPHI CONSULTING GROUP
K953833	LIFE SOUND SENSOR AMPLIFIER-LISA	Dec 05, 1995	Substantially Equivalent	FLOWSCAN, INC.
K950760	ANALYST, MODEL DSP 300	Oct 31, 1995	Substantially Equivalent	HEART SOUNDS, INC.
K953218	AUSCULATOR GPS	Sep 18, 1995	Substantially Equivalent	LYTE INDUSTRIES, INC.
K945638	TELPHONIC STETHOSCOPE	May 17, 1995	Substantially Equivalent	AMERICAN TELECARE, INC.
K941763	ELECTRONIC-AMPLIFIED STETHOSCOPE	Sep 06, 1994	Substantially Equivalent	HSUES' BROTHERS MEDICAL, INC.
K920009	3M LITTMANN GRAPHIC DISPLAY SYSTEM	Oct 21, 1992	Substantially Equivalent	3M HEALTH CARE, LTD.
K893557	ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)	Mar 19, 1990	Substantially Equivalent	MEDICAL MONITORS, INC.
K892890	STETH-SHIELD(TM)	Dec 01, 1989	Substantially Equivalent	NORTH EAST TECHNOLOGY
K882716	PROCEDURE PACKS SOLUTION ADMINISTRATION SETS	Sep 16, 1988	Substantially Equivalent	PROCEDURE PACKS, INC.
K874726	MASCOT STETHOSCOPE PROBE	Mar 31, 1988	Substantially Equivalent	IMEX MEDICAL SYSTEMS, INC.
K870810	DORCHES(TM) LIFESOUND(TM)	Jun 29, 1987	Substantially Equivalent	CENTAURI MANUFACTURING, INC.
K864278	DS-II DIGITAL SONOGRAPHY SYSTEM	Jun 10, 1987	Substantially Equivalent	INTL. ACOUSTICS, INC.
K860994	DECITEL AUSCULSCOPE	Nov 07, 1986	Substantially Equivalent	BLOOMFIELD RESEARCH AND DEVELOPMENT, INC.
K854772	TRANSCOR (TM) RADIO-STETHOSCOPE	May 13, 1986	Substantially Equivalent	K & S MEDICORP
K854356	STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE	May 05, 1986	Substantially Equivalent	FONTAINE INDUSTRIES, INC.
K844804	LIFESOUND - ELECTRONIC STETHOSCOPE	Feb 13, 1985	Substantially Equivalent	BIOMEDICAL CONCEPTS, INC.
K842705	MX2 ELECTRONIC STETHOSCOPE	Jan 23, 1985	Substantially Equivalent	MEDMAX, INC.
K831763	MAX I	Jan 27, 1984	Substantially Equivalent	TRADE MAX, INC.
K832882	DIF-STET	Dec 06, 1983	Substantially Equivalent	INTERSECT SYSTEMS, INC.
K812148	ELECTRONIC STETHOSCOPE #S-50	Aug 25, 1981	Substantially Equivalent	SYPHGMOSTAT
K801189	CONPHAR SUPERTONE STETHOSCOPE	Jun 04, 1980	Substantially Equivalent	CONPHAR, INC.
K801165	HYPERSTETHOSCOPE, MODEL Z 00	May 23, 1980	Substantially Equivalent	DEMONBINDER ELECTRONICS
K792112	CONPHAR STETHSCOPE	Dec 04, 1979	Substantially Equivalent	CONPHAR, INC.
K791338	DUAL HEAD STETHOSCOPE	Aug 10, 1979	Substantially Equivalent	AMDIA MEDICAL PRODUCTS
K791335	NURSESCOPE	Aug 10, 1979	Substantially Equivalent	AMDIA MEDICAL PRODUCTS
K791334	MULTISCOPE	Aug 10, 1979	Substantially Equivalent	AMDIA MEDICAL PRODUCTS
K791333	BOWLES STETHOSCOPE	Aug 10, 1979	Substantially Equivalent	AMDIA MEDICAL PRODUCTS
K780738	PENTAX ST-1A	Jul 17, 1978	Substantially Equivalent	HAL-HEN CO., INC.
K772173	STETHOSCOPE, ELECTRONIC	Jan 24, 1978	Substantially Equivalent	AFFILIATED MAILORDER CO. SALES, INC.
K771520	ESOPHAGEAL STETHOSCOPE	Sep 23, 1977	Substantially Equivalent	LABARGE, INC.
K771653	ELECTRONIC STETHOSCOPE	Sep 12, 1977	Substantially Equivalent	3M COMPANY
K771581	STETHOSCOPE, NURSESCOPE TYPE	Aug 26, 1977	Substantially Equivalent	SWARTZ MEDICAL EQUIPMENT
K771506	STETHOSCOPE	Aug 26, 1977	Substantially Equivalent	SWARTZ MEDICAL EQUIPMENT
K771505	STETHOSCOPE	Aug 26, 1977	Substantially Equivalent	SWARTZ MEDICAL EQUIPMENT
K771504	STETHOSCOPE	Aug 26, 1977	Substantially Equivalent	SWARTZ MEDICAL EQUIPMENT

FEI Numbers

This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.

1000292048: 59 registrations

1000548922: 11 registrations

1629623: 2 registrations

1926681: 166 registrations

2110898: 169 registrations

2434008: 69 registrations

3000130829: 2 registrations

3002865632: 3 registrations

3003174284: 9 registrations

3003399824: 9 registrations

3004009431: 11 registrations

3004215265: 1 registration

3004582233: 2 registrations

3004631140: 7 registrations

3009243923: 13 registrations

3009715978: 19 registrations

3009756153: 50 registrations

3010106598: 2 registrations

3010148504: 4 registrations

3010262192: 13 registrations

3011359729: 3 registrations

3011651230: 8 registrations

3012421607: 606 registrations

3012494290: 762 registrations

3012678246: 11 registrations

3013557562: 654 registrations

3013757696: 7 registrations

3015134086: 9 registrations

3015907115: 11 registrations

3016442138: 1 registration

3016678045: 154 registrations

3016864576: 3 registrations

3017829091: 3 registrations

3018117676: 2 registrations

3018783553: 2 registrations

3019891870: 4 registrations

3022172050: 2 registrations

3023869633: 2 registrations

3024491912: 1 registration

3030126961: 1 registration

3030626857: 33 registrations

3038129050: 1 registration