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 |