FDA 510(k) Applications for Medical Device Product Code "HGM"
(System, Monitoring, Perinatal)

FDA 510(k) Number Applicant Device Name Decision Date
K030261 ACCESS BATTERY, INC. BATTERY, RECHARGEABLE 04/24/2003
K112159 ADVANCED INSTRUMENTATIONS, INC. CMS-1000FM CENTRAL MONITORING SYSTEM 09/21/2011
K112187 ADVANCED INSTRUMENTATIONS, INC. FM-1000 PLUS FETAL MONITOR 09/21/2011
K141194 ADVANCED INSTRUMENTATIONS, INC. FM-3000 FETAL MONITOR 11/19/2014
K112317 ADVANCED INSTRUMENTATIONS, INC. FM-9000 PLUS FETAL AND MATERNAL MONITOR 12/21/2011
K871383 ADVANCED TECHNOLOGY LABORATORIES, INC. FETALERT ADR FETAL MONITOR 06/01/1987
K821479 ADVANTAGE MEDICAL SYSTEMS, INC. CENTRAL DISPLAY SYSTEM #CS400 06/25/1982
K821580 ADVANTAGE MEDICAL SYSTEMS, INC. FETAL MONITOR #FM 750 06/25/1982
K832849 ADVANTAGE MEDICAL SYSTEMS, INC. FETAL MONITOR #FM-2 10/04/1983
K800013 ADVANTAGE MEDICAL SYSTEMS, INC. FETAL MONITOR MODEL FHM-1 03/07/1980
K844724 ADVANTAGE MEDICAL SYSTEMS, INC. FETAL TELEMETRY SYSTEM 05/01/1985
K861455 ADVANTAGE MEDICAL SYSTEMS, INC. MODEL DT-102 DATA TELEPHONE TRANSMITTER 05/30/1986
K940898 ADVANTAGE MEDICAL SYSTEMS, INC. MODEL IM77 INTRAPARTUM FETAL MONITOR 03/01/1995
K955931 ADVANTAGE MEDICAL SYSTEMS, INC. MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) 08/14/1996
K852518 ADVANTAGE MEDICAL SYSTEMS, INC. MODIFICATION FETAL MONITOR MODEL FM-2 07/05/1985
K861556 ADVANTAGE MEDICAL SYSTEMS, INC. MODIFIED FETAL MONITOR MODEL FM-2 07/07/1986
K821478 ADVANTAGE MEDICAL SYSTEMS, INC. TELEPHONE LINK DATA TRANSMISSION SYS 07/26/1982
K771541 AIR-SHIELDS, INC. FETAL MONITORING SYSTEM 08/25/1977
K974248 AIR-SHIELDS, INC. WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM 10/07/1998
K090061 AIRSTRIP TECHNOLOGIES, LP AIRSTRIP OB 01/23/2009
K090269 AIRSTRIP TECHNOLOGIES, LP AIRSTRIP OB 02/13/2009
K173715 AlertWatch, Inc. AlertWatch:OB 04/23/2018
K971099 ALEXANDER MFG. CO. ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169 06/05/1997
K040819 AMERICAN I.V. PRODUCTS, INC. TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 08/16/2004
K910169 ANALOGIC CORP. FETALGARD 2000 07/22/1991
K950420 ANALOGIC CORP. FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 05/15/1995
K983395 ANALOGIC CORP. FETALGARD 3000 FETAL MONITOR 08/12/1999
K002503 ANALOGIC CORP. FETALGARD LITE 11/09/2000
K011304 ANALOGIC CORP. OB-1 FETAL MONITOR 05/29/2001
K905606 ATHEUS CORP. EXTERNAL FETAL MONITOR TRANSDUCER HOLDER 03/12/1991
K043598 BIONET CO., LTD. FC 1400 FETAL MONITOR 12/16/2005
K043597 BIONET CO., LTD. FC 700 FETAL MONITOR 12/16/2005
K994008 BIOSYS CO. LTD. BIOSYS FETAL MONITOR, MODEL IFM-500 09/29/2000
K121267 BISTOS CO., LTD. BT-200V VASCULAR DOPPLER 08/02/2012
K103545 BISTOS CO., LTD. BT-350 05/13/2011
K100885 BISTOS CO., LTD. FETAL MONITOR MODEL: BT-200T 06/07/2010
K052190 BISTOS CO., LTD. FETAL MONITOR, MODELS BT-300 AND BT-200 10/04/2005
K142799 Bistos Co., Ltd. Model BT-220L and BT-220C 07/09/2015
K770297 BRATTLE INSTRUMENT CORP. FETAL MONITOR, PART #100-11009 03/09/1977
K770296 BRATTLE INSTRUMENT CORP. FETAL MONITOR, PART #101-11009 03/09/1977
K770692 BRATTLE INSTRUMENT CORP. MONITOR, FETAL, NO. L04-1100 04/26/1977
K960553 CARD GUARD SCIENTIFIC SURVIVAL, LTD. CARD GUARD MODEL CG-900 04/22/1997
K010552 CARD GUARD SCIENTIFIC SURVIVAL, LTD. CG-900P FETAL/MATERNAL MONITOR 05/11/2001
K021574 CARD GUARD SCIENTIFIC SURVIVAL, LTD. TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER 08/12/2002
K091251 CERNER CORP. CERNER FETALINK (VERSION 1.0) 08/25/2009
K121758 CERNER CORP. CERNER FETALINK+(VERSION1.0) 10/09/2012
K050826 CETRO AMERICA FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS 04/10/2006
K051175 CIVENT COMMUNICATIONS LTD CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION 02/17/2006
K103172 CIVNET COMMUNICATION LTD CIV-OB (PLUS) 03/11/2011
K852704 CLINCAL INSTRUMENTS CORP. TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT 11/26/1985
K121208 CLINICAL COMPUTER SYSTEMS, INC. OBIX PERINATAL DATA SYSTEM 7.0 06/14/2012
K931133 CLINICOMP, INC. CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP 03/29/1995
K813458 CRANBURY MEDICAL LABS, INC. FETASCAN 1000, 1000A OBSTETRICAL DATA 01/28/1982
K813457 CRANBURY MEDICAL LABS, INC. FETASCAN 2000,2000A OBSTETRICAL DATA 02/12/1982
K822830 CRANBURY MEDICAL LABS, INC. MEDICAL LABS FETAL SCAN #1000 W/CENTRAL 09/30/1982
K903992 CYGNET CO., INC. CYGNET CENTRAL 12/19/1990
K050234 E.CARE SOLUTIONS, INC. REMOTE CARE 08/25/2005
K143695 EDAN INSTRUMENTS INC CENTRAL MONITORING SYSTEM 03/30/2015
K173042 Edan Instruments, Inc Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 08/30/2018
K073221 EDAN INSTRUMENTS, INC. CADENCE II 12/28/2007
K082369 EDAN INSTRUMENTS, INC. CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR 11/07/2008
K040903 EDAN INSTRUMENTS, INC. CADENCE, MODELS 2001 AND 2002 09/02/2004
K171178 Edan Instruments, Inc. Central Monitoring System 09/06/2017
K100358 EDAN INSTRUMENTS, INC. CENTRAL MONITORING SYSTEM 01/06/2011
K082602 EDAN INSTRUMENTS, INC. FETAL & MATERNAL MONITOR, MODEL F6, F9 11/26/2008
K150901 EDAN INSTRUMENTS, INC. Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express 07/01/2015
K100797 EDAN INSTRUMENTS, INC. FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS 11/10/2010
K102140 EDAN INSTRUMENTS, INC. FETAL MONITORS, MODELS F2 AND F3 01/13/2011
K813007 EPCOM MEDICAL SYSTEMS, INC. EPCOM EMS-180 ANTEPARTUM FETAL MONITOR 12/10/1981
K831113 EPCOM MEDICAL SYSTEMS, INC. EPCOM EMS-310 INTRAPARTUM MONITOR 08/12/1983
K831115 EPCOM MEDICAL SYSTEMS, INC. EPCOM EMS-320 REMOTE MONITORSCOPE 08/12/1983
K831114 EPCOM MEDICAL SYSTEMS, INC. EPCOM EMS-330 FREEDOM I TELEDOP OBSTET 08/12/1983
K171865 Farus, LLC F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring 08/24/2017
K871385 FUKUDA DENSHI USA, INC. MODEL U-1000 WITH GESTATIONAL AGE CALCULATION 05/26/1987
K761139 G.D. SEARLE AND CO. T-M (TIME-MOTION) OPTION 12/16/1976
K072976 GE HEALTHCARE MODEL 250CX SERIES MATERNAL/FETAL MONITOR 12/20/2007
K111614 GE HEALTHCARE INTEGRATED IT SOLUTIONS CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE 09/26/2011
K905295 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CATALOG NUMBER 2609 LEG PLATE 02/19/1991
K843385 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS 115 FETAL MONITOR 11/29/1984
K851252 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME 05/22/1985
K964770 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR 02/21/1997
K841477 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS 815 FETAL ECG RECORDER 05/14/1984
K843918 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS FETAL MONITOR 142 12/17/1984
K955559 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS FETAL MOVEMENT DETECTION KIT 03/05/1996
K910260 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST 03/15/1991
K920376 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS MODEL 150 FETAL MONITOR 04/27/1992
K993751 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES COROMETRICS MODEL 173 FETAL MONITOR 02/02/2000
K780176 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DISPLAY SYSTEM MODEL 428 03/02/1978
K831852 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES FETAL MONITOR #115 08/11/1983
K780177 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES FETAL MONITOR MODEL 112 03/02/1978
K891595 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 116 FETAL MONITOR 06/12/1989
K934959 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 118 FETAL/MATERNAL MONITOR 08/15/1994
K032252 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 120 SERIES MATERNAL/FETAL MONITOR 08/21/2003
K852076 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 145 FETAL MONITOR 07/05/1985
K932077 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 151 FETAL MONITOR 03/31/1994
K021135 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 2120IS SERIES MATERNAL/FETAL MONITOR 05/09/2002
K050583 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 250 SERIES MATERNAL/FETAL MONITOR 06/21/2005
K882966 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM 10/05/1988
K894958 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM 11/03/1989
K895045 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 410T TELECOMMUNICATION SYSTEM 11/06/1989
K880419 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 800 O.B. DATA ARCHIVAL SYSTEM 06/10/1988
K904358 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL 10/05/1990
K012718 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. 11/13/2001
K790139 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MONITOR, OFFICE MODEL 140 02/16/1979
K852608 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM 09/27/1985
K991739 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR 08/19/1999
K991905 GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN COROMETRICS MODEL 171 AND 172 FETAL MONITOR 09/01/1999
K910418 GRAPHIC CONTROLS CORP. LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 07/16/1991
K131941 GUANGDONG BIOLIGHT MEDITECH CO., LTD FETAL MONITORS 05/15/2014
K153580 GUANGDONG BIOLIGHT MEDITECH CO., LTD. Central Monitoring System 09/07/2016
K771194 HEWLETT-PACKARD CO. FETAL/MATERNAL ALRM MODULE - 21595A 08/03/1977
K771195 HEWLETT-PACKARD CO. FETAL/MATERNAL REPEATER - 21596A 08/03/1977
K921956 HEWLETT-PACKARD CO. HEWLETT PACKARD MODEL M1353A FETAL MONITOR 09/24/1993
K921957 HEWLETT-PACKARD CO. HEWLETT-PACKARD MODEL M1351A FETAL MONITOR 09/24/1993
K900480 HEWLETT-PACKARD CO. M1350A FETAL MONITOR (INTRAPARTUM) 07/02/1990
K771196 HEWLETT-PACKARD CO. MARKER GENERATOR MODULES - 21597A 08/03/1977
K781359 HEWLETT-PACKARD CO. MODEL 80032A, OBSTETRICAL TELEMETRY 09/26/1978
K781360 HEWLETT-PACKARD CO. MODEL 80100A, PATIENT DATA MEMORY 09/07/1978
K861544 HEWLETT-PACKARD CO. MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM 07/18/1986
K942887 HEWLETT-PACKARD CO. MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM 08/15/1994
K892354 HEWLETT-PACKARD CO. ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A 08/08/1989
K970456 HEWLETT-PACKARD GMBH HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM 10/03/1997
K954351 HEWLETT-PACKARD GMBH SERIES 50XM 03/08/1996
K014094 HILL-ROM MANUFACTURING, INC. MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM 01/11/2002
K032772 HILL-ROM MANUFACTURING, INC. MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM 10/08/2003
K080226 HILL-ROM MANUFACTURING, INC. NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 04/09/2008
K912138 HOMEVUE HEALTH SYSTEMS, INC. HOMEVUE MONITORING SYS.MODEL TD 2000 03/19/1992
K001677 HUNTLEIGH DIAGNOSTICS LTD. BABY DOPPLEX 4000 (BD4000) 08/14/2000
K002548 HUNTLEIGH DIAGNOSTICS LTD. FETAL ASSIST 03/06/2001
K132650 HUNTLEIGH HEALTHCARE LIMITED SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM 02/07/2014
K060230 HUNTLEIGH HEALTHCARE LTD. DOPPLEX CENTRALE 03/23/2006
K090285 HUNTLEIGH HEALTHCARE LTD. SONICAID FM820 AND FM830 ENCORE 07/15/2009
K963711 HUNTLEIGH HEALTHCARE, INC. BABY DOPPLEX (3000) 09/12/1997
K010889 HUNTLEIGH HEALTHCARE, INC. BABY DOPPLEX 3000 MK 2 (BD3000) 04/25/2001
K010894 HUNTLEIGH HEALTHCARE, INC. BABY DOPPLEX 3002 (BD3002) 04/25/2001
K990569 HUNTLEIGH HEALTHCARE, INC. BABY DOPPLEX 4000, MODEL BD 4000 01/24/2000
K001882 HUNTLEIGH HEALTHCARE, INC. BABY DOPPLEX 4002-TWINS, MODEL BD4002 09/19/2000
K823188 HUNTLEIGH TECHNOLOGY, INC. M2000 INTRAPARTUM FETAL MONITOR 01/26/1983
K823081 HUNTLEIGH TECHNOLOGY, INC. M2100 ANTEPARTUM FETAL MONITOR 01/26/1983
K860295 INTERNATIONAL BIOMEDICS, INC. FETASCAN 1500 05/19/1986
K812863 KONTRON INSTRUMENTS, INC. FETASONDE 5, #30, CENTRAL NURSING STAT 11/06/1981
K842422 KONTRON INSTRUMENTS, INC. KONTRON FAX FETAL MONITOR 09/20/1985
K052715 LMS MEDICAL SYSTEMS (CANADA), LTD. CALM CURVE, VERSION 01.00 12/22/2005
K980719 LMS MEDICAL SYSTEMS LTD. CALM 07/31/1998
K040788 LMS MEDICAL SYSTEMS LTD. CALM PATTERNS, VERSION 01.00.00 02/08/2005
K902802 MACON & CO., INC. FETAL MONITORING TRANSDUCER STRAP 09/04/1990
K993008 MARQUETTE MEDICAL SYSTEMS, INC. QUANTITATIVE SENTINEL SYSTEM 12/06/1999
K102263 MCKESSON INFORMATION SOLUTIONS LLC HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 05/05/2011
K110612 MEDIANA CO., LTD. FM20 11/08/2011
K761201 METRIX CO. ECHO-CARDIOTRACE, AUTOMATIC 01/12/1977
K161902 MINDCHILD MEDICAL Meridian M110 Fetal Monitoring System 01/12/2017
K120018 MINDCHILD MEDICAL MINDCHILD MERIDIAN FETAL HEART RATE MONITOR 09/19/2012
K142883 Mindchild Medical MindChild Meridian M100 Fetal Heart Rate Monitor 04/17/2015
K893981 MONOX, INC. WATCHCHILD 04/20/1990
K042082 MP4 SOLUTIONS, LP AIRSTRIP OB 01/21/2005
K925572 NEWARD ENTERPRISES, INC. MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE 10/08/1993
K013281 NICOLET BIOMEDICAL VERSALAB APM 04/18/2002
K860237 NIHON KOHDEN AMERICA, INC. OMF-7101 FETAL MONITOR 09/05/1986
K150398 OB TOOLS, LTD. EUM 100Pro 08/06/2015
K002150 OXFORD INSTRUMENTS SONICAID FM820, SONICAID FM830 03/09/2001
K023618 OXFORD INSTRUMENTS MEDICAL LTD. SONICAID ONE 01/22/2003
K992607 OXFORD INSTRUMENTS MEDICAL SYSTEMS SONICAID SYSTEM 8002 04/27/2001
K912890 OXFORD MEDILOG, INC. MODEL SONICAID AXIS 01/09/1992
K902690 OXFORD MEDILOG, INC. SONICAID MODEL MERIDIAN 800 02/05/1991
K912639 OXFORD MEDILOG, INC. SONICAID TEAM 12/31/1991
K882084 PEDIATRIC DIAGNOSTIC SERVICE GENESIS TM FETAL SYSTEM 05/26/1989
K855044 PERITRONICS RESEARCH AND DEVELOPMENT, INC. PERINATAL COMPUTER SYS MODEL 100A & 100B 03/12/1986
K870692 PERITRONICS RESEARCH AND DEVELOPMENT, INC. PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085 05/04/1987
K023931 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A 02/24/2003
K140535 PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 11/25/2014
K102958 PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH PHILIPS AVALON FETAL MONITOR 03/18/2011
K081203 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 05/28/2008
K092028 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 02/17/2010
K100420 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS OBTRACEVUE MODEL SW REV. G.00 07/26/2010
K062137 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 08/24/2006
K052795 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 12/30/2005
K071800 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN PHILIPS AVALON FETAL MONITORS FM20 AND FM30 09/27/2007
K111083 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 08/17/2011
K871082 PIE DATA MEDICAL BV FETAL CARE MONITOR ANTEPARTUM 1500 08/04/1987
K960109 QUANTITATIVE MEDICINE, INC. QUANTITATIVE SENTINEL SYSTEM 08/01/1996
K963608 QUANTITATIVE MEDICINE, INC. QUANTITATIVE SENTINEL SYSTEM 03/11/1997
K935301 R & D BATTERIES, INC. R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050 12/05/1994
K935377 R & D BATTERIES, INC. R AND D BATTERIES 12/05/1994
K791035 ROCHE MEDICAL ELECTRONICS, INC. FETASONDE FETAL ACTIVITY MONITOR 09/04/1979
K791039 ROCHE MEDICAL ELECTRONICS, INC. FETASONDE FETAL HEART RATE VARIABILITY 09/04/1979
K791037 ROCHE MEDICAL ELECTRONICS, INC. FETASONDE LABOR STATUS DISPLAY 09/04/1979
K790761 ROCHE MEDICAL ELECTRONICS, INC. FETASONDE MODEL 2108 06/01/1979
K791038 ROCHE MEDICAL ELECTRONICS, INC. FETASONDE UTERINE ACTIVITY MONITOR 09/04/1979
K791036 ROCHE MEDICAL ELECTRONICS, INC. FETASONDE UTERINE WORK MONITOR 09/04/1979
K760919 ROCHE MEDICAL ELECTRONICS, INC. MODEL 2106 FETA SONDE FETAL MONITOR 11/16/1976
K132918 SENSE4BABY, INC. SENSE-4BABY SYSTEM 11/22/2013
K761030 SMITH KLINE DIAGNOSTICS, INC. EKOSECTOR I 12/13/1976
K771379 SONICAID, INC. FETAL MONITORING SYS. MODEL FM3R 08/03/1977
K812256 SONICAID, INC. MODEL AP 180 MINI-MONITOR 10/20/1981
K831371 SONICAID, INC. MODEL FM5 06/30/1983
K965008 SPACELABS MEDICAL, INC. BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM 12/16/1997
K123335 SUNRAY MEDICAL APPARATUS CO., LTD. SUNRAY FETAL MONITOR 03/21/2013
K861189 TECNOL NEW JERSEY WOUND CARE, INC. TECNOL SECURE-ALL FETAL MONITOR STRAP 04/08/1986
K043075 TENACORE HOLDINGS, INC. TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING 08/18/2005
K801747 TERUMO MEDICAL CORP. TERUMO FETAL MONITOR # FHM-602 08/13/1980
K894036 TOITU OF AMERICA, INC. TOITU FETAL ACTOCARDIOGRAPH, MT-332 11/06/1989
K110556 WIPRO GE HEALTHCARE PRIVATE, LTD. MINI TELEMETRY SYSTEM 07/19/2011
K892501 WRIGHT MEDICAL CORP. WRIGHT MEDICAL FETASAFE 09/12/1989


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