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 |
| K955931 | ADVANCED MEDICAL SYSTEMS, INC. | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) | 08/14/1996 |
| 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 |
| 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 |
| 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 |
| K222327 | Bloom Technologies NV | Bloomlife MFM-Pro | 02/13/2023 |
| 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 |
| K121208 | CLINICAL COMPUTER SYSTEMS, INC. | OBIX PERINATAL DATA SYSTEM 7.0 | 06/14/2012 |
| 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 |
| K171865 | Farus, LLC | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | 08/24/2017 |
| 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 |
| K964770 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR | 02/21/1997 |
| K955559 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | COROMETRICS FETAL MOVEMENT DETECTION KIT | 03/05/1996 |
| K993751 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | COROMETRICS MODEL 173 FETAL MONITOR | 02/02/2000 |
| K032252 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MODEL 120 SERIES MATERNAL/FETAL MONITOR | 08/21/2003 |
| 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 |
| K012718 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. | 11/13/2001 |
| K220732 | GE Medical Systems Information Technologies, Inc. | Mural Perinatal Surveillance | 06/23/2022 |
| 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 |
| K131941 | GUANGDONG BIOLIGHT MEDITECH CO., LTD | FETAL MONITORS | 05/15/2014 |
| K153580 | GUANGDONG BIOLIGHT MEDITECH CO., LTD. | Central Monitoring System | 09/07/2016 |
| 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 |
| 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 |
| K200975 | Huntleigh Healthcare Limited | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | 06/24/2020 |
| 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 |
| 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 |
| 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 |
| 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 |
| K042082 | MP4 SOLUTIONS, LP | AIRSTRIP OB | 01/21/2005 |
| K013281 | NICOLET BIOMEDICAL | VERSALAB APM | 04/18/2002 |
| 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 |
| 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 |
| K173941 | Philips Medizin Systeme Boeblingen GmbH | IntelliSpace Perinatal Rev.K.00 | 09/10/2018 |
| 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 |
| K960109 | QUANTITATIVE MEDICINE, INC. | QUANTITATIVE SENTINEL SYSTEM | 08/01/1996 |
| K963608 | QUANTITATIVE MEDICINE, INC. | QUANTITATIVE SENTINEL SYSTEM | 03/11/1997 |
| K132918 | SENSE4BABY, INC. | SENSE-4BABY SYSTEM | 11/22/2013 |
| 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 |
| K043075 | TENACORE HOLDINGS, INC. | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | 08/18/2005 |
| K110556 | WIPRO GE HEALTHCARE PRIVATE, LTD. | MINI TELEMETRY SYSTEM | 07/19/2011 |
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