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
K771653 3M COMPANY ELECTRONIC STETHOSCOPE 09/12/1977
K050159 3M COMPANY MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 02/22/2005
K920009 3M HEALTH CARE, LTD. 3M LITTMANN GRAPHIC DISPLAY SYSTEM 10/21/1992
K103499 ACTIVE SIGNAL TECHNOLOGIES, INC. A SCOPE 03/31/2011
K772173 AFFILIATED MAILORDER CO. SALES, INC. STETHOSCOPE, ELECTRONIC 01/24/1978
K993623 ALLEN MEDICAL INSTRUMENTS CORP. GEMINI E 06/23/2000
K791333 AMDIA MEDICAL PRODUCTS BOWLES STETHOSCOPE 08/10/1979
K791338 AMDIA MEDICAL PRODUCTS DUAL HEAD STETHOSCOPE 08/10/1979
K791334 AMDIA MEDICAL PRODUCTS MULTISCOPE 08/10/1979
K791335 AMDIA MEDICAL PRODUCTS NURSESCOPE 08/10/1979
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
K945638 AMERICAN TELECARE, INC. TELPHONIC STETHOSCOPE 05/17/1995
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
K991756 BIO-RESEARCH ASSOCIATES, INC. 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE 12/10/1999
K844804 BIOMEDICAL CONCEPTS, INC. LIFESOUND - ELECTRONIC STETHOSCOPE 02/13/1985
K860994 BLOOMFIELD RESEARCH AND DEVELOPMENT, INC. DECITEL AUSCULSCOPE 11/07/1986
K990809 CADITEC AG CADISCOPE ELECTRONIC STETHOSCOPE 06/09/1999
K870810 CENTAURI MANUFACTURING, INC. DORCHES(TM) LIFESOUND(TM) 06/29/1987
K801189 CONPHAR, INC. CONPHAR "SUPERTONE" STETHOSCOPE 06/04/1980
K792112 CONPHAR, INC. CONPHAR STETHSCOPE 12/04/1979
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
K801165 DEMONBINDER ELECTRONICS HYPERSTETHOSCOPE, MODEL Z 00 05/23/1980
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
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
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
K953833 FLOWSCAN, INC. LIFE SOUND SENSOR AMPLIFIER-LISA 12/05/1995
K854356 FONTAINE INDUSTRIES, INC. STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE 05/05/1986
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
K780738 HAL-HEN CO., INC. PENTAX ST-1A 07/17/1978
K100531 HD MEDICAL SERVICES (INDIA) PVT.LTD VISCOPE, MODEL 100P,100S 07/21/2010
K050169 HEALTH & LIFE CO., LTD. HL 200 ELECTRONIC STETHOSCOPE 04/05/2005
K950760 HEART SOUNDS, INC. ANALYST, MODEL DSP 300 10/31/1995
K941763 HSUES' BROTHERS MEDICAL, INC. ELECTRONIC-AMPLIFIED STETHOSCOPE 09/06/1994
K160023 IMEDIPLUS INC. Electronic Stethoscope DS301 09/30/2016
K173663 IMEDIPLUS INC. Electronic Stethoscope DS3011A 08/17/2018
K874726 IMEX MEDICAL SYSTEMS, INC. "MASCOT" STETHOSCOPE PROBE 03/31/1988
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
K832882 INTERSECT SYSTEMS, INC. DIF-STET 12/06/1983
K864278 INTL. ACOUSTICS, INC. DS-II DIGITAL SONOGRAPHY SYSTEM 06/10/1987
K854772 K & S MEDICORP TRANSCOR (TM) RADIO-STETHOSCOPE 05/13/1986
K070550 KORATEK COMPANY, LTD. AUSCO ES-3100 11/06/2007
K771520 LABARGE, INC. ESOPHAGEAL STETHOSCOPE 09/23/1977
K953218 LYTE INDUSTRIES, INC. AUSCULATOR GPS 09/18/1995
K172296 M3dicine Pty. Ltd. Stethee Pro 10/30/2017
K893557 MEDICAL MONITORS, INC. ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING) 03/19/1990
K013725 MEDITRON AS MEDITRON II THESTERTHOSCOPE SYSTEM 01/30/2002
K991367 MEDITRON AS MEDITRON STETHOSCOPE SYSTEM 07/19/1999
K842705 MEDMAX, INC. MX2 ELECTRONIC STETHOSCOPE 01/23/1985
K961848 MINNESOTA MINING AND MFG. CO. 3M LITTMANN ELECTRONIC STETHOSCOPE 09/26/1997
K082528 NOBLE ANESTHESIA-AIR, INC. SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM 03/06/2009
K892890 NORTH EAST TECHNOLOGY STETH-SHIELD(TM) 12/01/1989
K123148 PARACE LLC PARACE MD EKOSCOPE IS100 11/19/2013
K062481 PISHON HIGH TECH CO., LTD. SERENO ELECTRONIC STETHOSCOPE 10/16/2006
K882716 PROCEDURE PACKS, INC. PROCEDURE PACKS SOLUTION ADMINISTRATION SETS 09/16/1988
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
K121144 SHARP CORPORATION ELECTRONIC STETHOSCOPE 09/26/2012
K023759 SONOMEDICA CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER 05/06/2003
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
K160016 STRATOSCIENTIFIC, INC. Steth IO 07/15/2016
K771504 SWARTZ MEDICAL EQUIPMENT STETHOSCOPE 08/26/1977
K771505 SWARTZ MEDICAL EQUIPMENT STETHOSCOPE 08/26/1977
K771506 SWARTZ MEDICAL EQUIPMENT STETHOSCOPE 08/26/1977
K771581 SWARTZ MEDICAL EQUIPMENT STETHOSCOPE, NURSESCOPE TYPE 08/26/1977
K812148 SYPHGMOSTAT ELECTRONIC STETHOSCOPE #S-50 08/25/1981
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
K831763 TRADE MAX, INC. MAX I 01/27/1984
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
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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