System, Monitoring, Perinatal
FDA product code HGM · 206 cleared devices
Class 2
Obstetrics/Gynecology
- Regulation
- 21 CFR 884.2740
- Review panel
- OB
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-16 – 2026-08-10
HGM
2026-08-10
HGM
2026-02-26
ANNE Maternal
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HGM
2025-09-19
Sonicaid Team3
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HGM
2025-08-27
Fetal & Maternal Monitor (F15A, F15A Air)
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HGM
2025-02-03
Sonicaid Team3
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HGM
2025-01-10
PeriCALM Patterns 3.0
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HGM
2024-07-02
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
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HGM
2023-12-08
Novii+ Wireless Patch System
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HGM
2023-02-13
Bloomlife MFM-Pro
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HGM
2022-06-23
Mural Perinatal Surveillance
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HGM
2020-06-24
Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
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HGM
2018-09-10
IntelliSpace Perinatal Rev.K.00
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HGM
2018-08-30
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
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HGM
2018-04-23
AlertWatch:OB
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HGM
2017-09-06
Central Monitoring System
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HGM
2017-08-24
F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
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HGM
2017-01-12
Meridian M110 Fetal Monitoring System
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HGM
2016-09-07
Central Monitoring System
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HGM
2013-11-22
SENSE-4BABY SYSTEM
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HGM
2013-03-21
SUNRAY FETAL MONITOR
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HGM
2012-10-09
CERNER FETALINK+(VERSION1.0)
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HGM
2012-09-19
MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
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HGM
2012-08-02
BT-200V VASCULAR DOPPLER
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HGM
2012-06-14
OBIX PERINATAL DATA SYSTEM 7.0
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HGM
2011-12-21
FM-9000 PLUS FETAL AND MATERNAL MONITOR
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HGM
2011-11-08
FM20
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HGM
2011-09-26
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
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HGM
2011-09-21
FM-1000 PLUS FETAL MONITOR
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HGM
2011-09-21
CMS-1000FM CENTRAL MONITORING SYSTEM
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HGM
2011-08-17
PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
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HGM
2011-07-19
MINI TELEMETRY SYSTEM
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HGM
2011-05-13
BT-350
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HGM
2011-05-05
HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
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HGM
2011-03-18
PHILIPS AVALON FETAL MONITOR
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HGM
2011-03-11
CIV-OB (PLUS)
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HGM
2011-01-13
FETAL MONITORS, MODELS F2 AND F3
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HGM
2011-01-06
CENTRAL MONITORING SYSTEM
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HGM
2010-11-10
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
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HGM
2010-07-26
PHILIPS OBTRACEVUE MODEL SW REV. G.00
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HGM
2010-06-07
FETAL MONITOR MODEL: BT-200T
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HGM
2010-02-17
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
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HGM
2009-08-25
CERNER FETALINK (VERSION 1.0)
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HGM
2009-07-15
SONICAID FM820 AND FM830 ENCORE
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HGM
2009-02-13
AIRSTRIP OB
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HGM
2009-01-23
AIRSTRIP OB
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HGM
2008-11-26
FETAL & MATERNAL MONITOR, MODEL F6, F9
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HGM
2008-11-07
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
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HGM
2008-05-28
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
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HGM
2008-04-09
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
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HGM
2007-12-28
CADENCE II
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HGM
2007-12-20
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
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HGM
2007-09-27
PHILIPS AVALON FETAL MONITORS FM20 AND FM30
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HGM
2006-08-24
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
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HGM
2006-04-10
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
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HGM
2006-03-23
DOPPLEX CENTRALE
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HGM
2006-02-17
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
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HGM
2005-12-30
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
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HGM
2005-12-22
CALM CURVE, VERSION 01.00
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HGM
2005-12-16
FC 1400 FETAL MONITOR
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HGM
2005-12-16
FC 700 FETAL MONITOR
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HGM
2005-10-04
FETAL MONITOR, MODELS BT-300 AND BT-200
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HGM
2005-08-25
REMOTE CARE
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HGM
2005-08-18
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
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HGM
2005-06-21
MODEL 250 SERIES MATERNAL/FETAL MONITOR
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HGM
2005-02-08
CALM PATTERNS, VERSION 01.00.00
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HGM
2005-01-21
AIRSTRIP OB
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HGM
2004-09-02
CADENCE, MODELS 2001 AND 2002
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HGM
2004-08-16
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
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HGM
2003-10-08
MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
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HGM
2003-08-21
MODEL 120 SERIES MATERNAL/FETAL MONITOR
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HGM
2003-04-24
BATTERY, RECHARGEABLE
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HGM
2003-02-24
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
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HGM
2003-01-22
SONICAID ONE
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HGM
2002-08-12
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
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HGM
2002-05-09
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
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HGM
2002-04-18
VERSALAB APM
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HGM
2002-01-11
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
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HGM
2001-11-13
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
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HGM
2001-05-29
OB-1 FETAL MONITOR
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HGM
2001-05-11
CG-900P FETAL/MATERNAL MONITOR
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HGM
2001-04-27
SONICAID SYSTEM 8002
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HGM
2001-04-25
BABY DOPPLEX 3002 (BD3002)
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HGM
2001-04-25
BABY DOPPLEX 3000 MK 2 (BD3000)
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HGM
2001-03-09
SONICAID FM820, SONICAID FM830
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HGM
2001-03-06
FETAL ASSIST
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HGM
2000-11-09
FETALGARD LITE
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HGM
2000-09-29
BIOSYS FETAL MONITOR, MODEL IFM-500
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HGM
2000-09-19
BABY DOPPLEX 4002-TWINS, MODEL BD4002
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HGM
2000-08-14
BABY DOPPLEX 4000 (BD4000)
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HGM
2000-02-02
COROMETRICS MODEL 173 FETAL MONITOR
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HGM
2000-01-24
BABY DOPPLEX 4000, MODEL BD 4000
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HGM
1999-12-06
QUANTITATIVE SENTINEL SYSTEM
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HGM
1999-09-01
COROMETRICS MODEL 171 AND 172 FETAL MONITOR
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HGM
1999-08-19
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
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HGM
1999-08-12
FETALGARD 3000 FETAL MONITOR
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HGM
1998-10-07
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
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HGM
1998-07-31
CALM
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HGM
1997-12-16
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
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HGM
1997-10-03
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
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HGM
1997-09-12
BABY DOPPLEX (3000)
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