FDA Product Code
FDA Product Code HGM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2740
510(k) Clearances — 215 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026-08-10 | Traditional | PDF ↗ |
| K253021 | ANNE Maternal | Sibel Health, Inc. | 2026-02-26 | Traditional | PDF ↗ |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-09-19 | Traditional | PDF ↗ |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025-08-27 | Traditional | PDF ↗ |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-02-03 | Traditional | PDF ↗ |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 | Traditional | PDF ↗ |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023-12-08 | Traditional | PDF ↗ |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | 2023-02-13 | Traditional | PDF ↗ |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 | Traditional | PDF ↗ |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020-06-24 | Traditional | PDF ↗ |
| K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018-09-10 | Traditional | PDF ↗ |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. | 2018-08-30 | Traditional | PDF ↗ |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018-04-23 | Traditional | PDF ↗ |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017-09-06 | Traditional | PDF ↗ |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC | 2017-08-24 | Traditional | PDF ↗ |
| K161902 | Meridian M110 Fetal Monitoring System | Mindchild Medical | 2017-01-12 | Traditional | PDF ↗ |
| K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016-09-07 | Traditional | PDF ↗ |
| K150398 | EUM 100Pro | Ob Tools, Ltd. | 2015-08-06 | Traditional | PDF ↗ |
| K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015-07-09 | Traditional | PDF ↗ |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | 2015-07-01 | Traditional | PDF ↗ |
| K142883 | MindChild Meridian M100 Fetal Heart Rate Monitor | Mindchild Medical | 2015-04-17 | Traditional | PDF ↗ |
| K143695 | CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | 2015-03-30 | Traditional | PDF ↗ |
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | Philips Medizin Systeme Boblingen GmbH | 2014-11-25 | Abbreviated | PDF ↗ |
| K141194 | FM-3000 FETAL MONITOR | Advanced Instrumentations, Inc. | 2014-11-19 | Traditional | PDF ↗ |
| K131941 | FETAL MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2014-05-15 | Traditional | PDF ↗ |
| K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM | Huntleigh Healthcare Limited | 2014-02-07 | Traditional | PDF ↗ |
| K132918 | SENSE-4BABY SYSTEM | Sense4baby , Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K123335 | SUNRAY FETAL MONITOR | Sunray Medical Apparatus Co., Ltd. | 2013-03-21 | Traditional | PDF ↗ |
| K121758 | CERNER FETALINK+(VERSION1.0) | Cerner Corp. | 2012-10-09 | Traditional | PDF ↗ |
| K120018 | MINDCHILD MERIDIAN FETAL HEART RATE MONITOR | Mindchild Medical | 2012-09-19 | Traditional | PDF ↗ |
| K121267 | BT-200V VASCULAR DOPPLER | Bistos Co., Ltd. | 2012-08-02 | Traditional | PDF ↗ |
| K121208 | OBIX PERINATAL DATA SYSTEM 7.0 | Clinical Computer Systems, Inc. | 2012-06-14 | Traditional | PDF ↗ |
| K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR | Advanced Instrumentations, Inc. | 2011-12-21 | Traditional | PDF ↗ |
| K110612 | FM20 | Mediana Co., Ltd. | 2011-11-08 | Traditional | PDF ↗ |
| K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE | Ge Healthcare Integrated IT Solutions | 2011-09-26 | Traditional | PDF ↗ |
| K112159 | CMS-1000FM CENTRAL MONITORING SYSTEM | Advanced Instrumentations, Inc. | 2011-09-21 | Traditional | PDF ↗ |
| K112187 | FM-1000 PLUS FETAL MONITOR | Advanced Instrumentations, Inc. | 2011-09-21 | Traditional | PDF ↗ |
| K111083 | PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-08-17 | Abbreviated | PDF ↗ |
| K110556 | MINI TELEMETRY SYSTEM | Wipro GE Healthcare Private, Ltd. | 2011-07-19 | Traditional | PDF ↗ |
| K103545 | BT-350 | Bistos Co., Ltd. | 2011-05-13 | Traditional | PDF ↗ |
| K102263 | HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 | Mckesson Information Solutions, LLC | 2011-05-05 | Traditional | PDF ↗ |
| K102958 | PHILIPS AVALON FETAL MONITOR | Philips Medizin Systeme Boblingen GmbH | 2011-03-18 | Traditional | PDF ↗ |
| K103172 | CIV-OB (PLUS) | Civnet Communication, Ltd. | 2011-03-11 | Traditional | PDF ↗ |
| K102140 | FETAL MONITORS, MODELS F2 AND F3 | Edan Instruments, Inc. | 2011-01-13 | Traditional | PDF ↗ |
| K100358 | CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | 2011-01-06 | Traditional | PDF ↗ |
| K100797 | FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS | Edan Instruments, Inc. | 2010-11-10 | Traditional | PDF ↗ |
| K100420 | PHILIPS OBTRACEVUE MODEL SW REV. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010-07-26 | Abbreviated | PDF ↗ |
| K100885 | FETAL MONITOR MODEL: BT-200T | Bistos Co., Ltd. | 2010-06-07 | Traditional | PDF ↗ |
| K092028 | PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 | Philips Medizin Systeme Boeblingen GmbH | 2010-02-17 | Traditional | PDF ↗ |
| K091251 | CERNER FETALINK (VERSION 1.0) | Cerner Corp. | 2009-08-25 | Traditional | PDF ↗ |
| K090285 | SONICAID FM820 AND FM830 ENCORE | Huntleigh Healthcare , Ltd. | 2009-07-15 | Traditional | PDF ↗ |
| K090269 | AIRSTRIP OB | Airstrip Technologies, LP | 2009-02-13 | Traditional | PDF ↗ |
| K090061 | AIRSTRIP OB | Airstrip Technologies, LP | 2009-01-23 | Traditional | PDF ↗ |
| K082602 | FETAL & MATERNAL MONITOR, MODEL F6, F9 | Edan Instruments, Inc. | 2008-11-26 | Traditional | PDF ↗ |
| K082369 | CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR | Edan Instruments, Inc. | 2008-11-07 | Special | PDF ↗ |
| K081203 | OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 | Philips Medizin Systeme Boeblingen GmbH | 2008-05-28 | Special | PDF ↗ |
| K080226 | NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 | Hill-Rom Manufacturing, Inc. | 2008-04-09 | Special | PDF ↗ |
| K073221 | CADENCE II | Edan Instruments, Inc. | 2007-12-28 | Special | PDF ↗ |
| K072976 | MODEL 250CX SERIES MATERNAL/FETAL MONITOR | GE Healthcare | 2007-12-20 | Special | PDF ↗ |
| K071800 | PHILIPS AVALON FETAL MONITORS FM20 AND FM30 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-09-27 | Abbreviated | PDF ↗ |
| K062137 | MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 | Philips Medizin Systeme Boeblingen GmbH | 2006-08-24 | Special | PDF ↗ |
| K050826 | FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS | Cetro America | 2006-04-10 | Traditional | PDF ↗ |
| K060230 | DOPPLEX CENTRALE | Huntleigh Healthcare , Ltd. | 2006-03-23 | Traditional | PDF ↗ |
| K051175 | CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION | Civent Communications, Ltd. | 2006-02-17 | Traditional | PDF ↗ |
| K052795 | PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 | Philips Medizin Systeme Boeblingen GmbH | 2005-12-30 | Special | PDF ↗ |
| K052715 | CALM CURVE, VERSION 01.00 | Lms Medical Systems (Canada), Ltd. | 2005-12-22 | Special | PDF ↗ |
| K043598 | FC 1400 FETAL MONITOR | Bionet Co., Ltd. | 2005-12-16 | Traditional | PDF ↗ |
| K043597 | FC 700 FETAL MONITOR | Bionet Co., Ltd. | 2005-12-16 | Traditional | PDF ↗ |
| K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 | Bistos Co., Ltd. | 2005-10-04 | Traditional | PDF ↗ |
| K050234 | REMOTE CARE | E.Care Solutions, Inc. | 2005-08-25 | Traditional | PDF ↗ |
| K043075 | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | Tenacore Holdings, Inc. | 2005-08-18 | Traditional | PDF ↗ |
| K050583 | MODEL 250 SERIES MATERNAL/FETAL MONITOR | Ge Medical Systems Information Technologies | 2005-06-21 | Special | PDF ↗ |
| K040788 | CALM PATTERNS, VERSION 01.00.00 | Lms Medical Systems , Ltd. | 2005-02-08 | Traditional | PDF ↗ |
| K042082 | AIRSTRIP OB | Mp4 Solutions, LP | 2005-01-21 | Traditional | PDF ↗ |
| K040903 | CADENCE, MODELS 2001 AND 2002 | Edan Instruments, Inc. | 2004-09-02 | Traditional | PDF ↗ |
| K040819 | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 | American I.V. Products, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K032772 | MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM | Hill-Rom Manufacturing, Inc. | 2003-10-08 | Special | PDF ↗ |
| K032252 | MODEL 120 SERIES MATERNAL/FETAL MONITOR | Ge Medical Systems Information Technologies | 2003-08-21 | Special | PDF ↗ |
| K030261 | BATTERY, RECHARGEABLE | Access Battery, Inc. | 2003-04-24 | Traditional | PDF ↗ |
| K023931 | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A | Philips Medical Systems, Inc. | 2003-02-24 | Traditional | PDF ↗ |
| K023618 | SONICAID ONE | Oxford Instruments Medical , Ltd. | 2003-01-22 | Special | PDF ↗ |
| K021574 | TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER | Card Guard Scientific Survival , Ltd. | 2002-08-12 | Traditional | PDF ↗ |
| K021135 | MODEL 2120IS SERIES MATERNAL/FETAL MONITOR | Ge Medical Systems Information Technologies | 2002-05-09 | Special | PDF ↗ |
| K013281 | VERSALAB APM | Nicolet Biomedical | 2002-04-18 | Abbreviated | PDF ↗ |
| K014094 | MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM | Hill-Rom Manufacturing, Inc. | 2002-01-11 | Special | PDF ↗ |
| K012718 | MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. | Ge Medical Systems Information Technologies | 2001-11-13 | Traditional | PDF ↗ |
| K011304 | OB-1 FETAL MONITOR | Analogic Corp. | 2001-05-29 | Special | PDF ↗ |
| K010552 | CG-900P FETAL/MATERNAL MONITOR | Card Guard Scientific Survival , Ltd. | 2001-05-11 | Special | PDF ↗ |
| K992607 | SONICAID SYSTEM 8002 | Oxford Instruments Medical Systems | 2001-04-27 | Traditional | PDF ↗ |
| K010894 | BABY DOPPLEX 3002 (BD3002) | Huntleigh Healthcare, Inc. | 2001-04-25 | Special | PDF ↗ |
| K010889 | BABY DOPPLEX 3000 MK 2 (BD3000) | Huntleigh Healthcare, Inc. | 2001-04-25 | Special | PDF ↗ |
| K002150 | SONICAID FM820, SONICAID FM830 | Oxford Instruments | 2001-03-09 | Traditional | PDF ↗ |
| K002548 | FETAL ASSIST | Huntleigh Diagnostics , Ltd. | 2001-03-06 | Traditional | PDF ↗ |
| K002503 | FETALGARD LITE | Analogic Corp. | 2000-11-09 | Traditional | PDF ↗ |
| K994008 | BIOSYS FETAL MONITOR, MODEL IFM-500 | Biosys Co. , Ltd. | 2000-09-29 | Traditional | PDF ↗ |
| K001882 | BABY DOPPLEX 4002-TWINS, MODEL BD4002 | Huntleigh Healthcare, Inc. | 2000-09-19 | Traditional | PDF ↗ |
| K001677 | BABY DOPPLEX 4000 (BD4000) | Huntleigh Diagnostics , Ltd. | 2000-08-14 | Special | PDF ↗ |
| K993751 | COROMETRICS MODEL 173 FETAL MONITOR | Ge Medical Systems Information Technologies | 2000-02-02 | Traditional | PDF ↗ |
| K990569 | BABY DOPPLEX 4000, MODEL BD 4000 | Huntleigh Healthcare, Inc. | 2000-01-24 | Traditional | PDF ↗ |
Product code HGM · Class II · Obstetrics/Gynecology. Data: openFDA.