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
1997-06-05
HGM
1997-04-22
CARD GUARD MODEL CG-900
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HGM
1997-03-11
QUANTITATIVE SENTINEL SYSTEM
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HGM
1997-02-21
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
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HGM
1996-08-14
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
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HGM
1996-08-01
QUANTITATIVE SENTINEL SYSTEM
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HGM
1996-03-08
SERIES 50XM
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HGM
1996-03-05
COROMETRICS FETAL MOVEMENT DETECTION KIT
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HGM
1995-05-15
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
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HGM
1995-03-29
CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP
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HGM
1995-03-01
MODEL IM77 INTRAPARTUM FETAL MONITOR
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HGM
1994-12-05
R AND D BATTERIES
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HGM
1994-12-05
R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050
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HGM
1994-08-15
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
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HGM
1994-08-15
MODEL 118 FETAL/MATERNAL MONITOR
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HGM
1994-03-31
MODEL 151 FETAL MONITOR
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HGM
1993-10-08
MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE
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HGM
1993-09-24
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
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HGM
1993-09-24
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
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HGM
1992-04-27
COROMETRICS MODEL 150 FETAL MONITOR
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HGM
1992-03-19
HOMEVUE MONITORING SYS.MODEL TD 2000
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HGM
1992-01-09
MODEL SONICAID AXIS
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HGM
1991-12-31
SONICAID TEAM
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HGM
1991-07-22
FETALGARD 2000
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HGM
1991-07-16
LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100
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HGM
1991-03-15
COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST
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HGM
1991-03-12
EXTERNAL FETAL MONITOR TRANSDUCER HOLDER
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HGM
1991-02-19
CATALOG NUMBER 2609 LEG PLATE
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HGM
1991-02-05
SONICAID MODEL MERIDIAN 800
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HGM
1990-12-19
CYGNET CENTRAL
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HGM
1990-10-05
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
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HGM
1990-09-04
FETAL MONITORING TRANSDUCER STRAP
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HGM
1990-07-02
M1350A FETAL MONITOR (INTRAPARTUM)
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HGM
1990-04-20
WATCHCHILD
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HGM
1989-11-06
MODEL 410T TELECOMMUNICATION SYSTEM
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HGM
1989-11-06
TOITU FETAL ACTOCARDIOGRAPH, MT-332
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HGM
1989-11-03
MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM
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HGM
1989-09-12
WRIGHT MEDICAL FETASAFE
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HGM
1989-08-08
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
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HGM
1989-06-12
MODEL 116 FETAL MONITOR
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HGM
1989-05-26
GENESIS TM FETAL SYSTEM
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HGM
1988-10-05
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
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HGM
1988-06-10
MODEL 800 O.B. DATA ARCHIVAL SYSTEM
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HGM
1987-08-04
FETAL CARE MONITOR ANTEPARTUM 1500
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HGM
1987-06-01
FETALERT ADR FETAL MONITOR
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HGM
1987-05-26
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
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HGM
1987-05-04
PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085
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HGM
1986-09-05
OMF-7101 FETAL MONITOR
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HGM
1986-07-18
MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
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HGM
1986-07-07
MODIFIED FETAL MONITOR MODEL FM-2
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HGM
1986-05-30
MODEL DT-102 DATA TELEPHONE TRANSMITTER
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HGM
1986-05-19
FETASCAN 1500
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HGM
1986-04-08
TECNOL SECURE-ALL FETAL MONITOR STRAP
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HGM
1986-03-12
PERINATAL COMPUTER SYS MODEL 100A & 100B
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HGM
1985-11-26
TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
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HGM
1985-09-27
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
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HGM
1985-09-20
KONTRON FAX FETAL MONITOR
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HGM
1985-07-05
MODIFICATION FETAL MONITOR MODEL FM-2
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HGM
1985-07-05
MODEL 145 FETAL MONITOR
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HGM
1985-05-22
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
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HGM
1985-05-01
FETAL TELEMETRY SYSTEM
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HGM
1984-12-17
COROMETRICS FETAL MONITOR 142
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HGM
1984-11-29
COROMETRICS 115 FETAL MONITOR
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HGM
1984-05-14
COROMETRICS 815 FETAL ECG RECORDER
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HGM
1983-10-04
FETAL MONITOR #FM-2
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HGM
1983-08-12
EPCOM EMS-320 REMOTE MONITORSCOPE
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HGM
1983-08-12
EPCOM EMS-330 FREEDOM I TELEDOP OBSTET
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HGM
1983-08-12
EPCOM EMS-310 INTRAPARTUM MONITOR
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HGM
1983-08-11
FETAL MONITOR #115
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HGM
1983-06-30
MODEL FM5
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HGM
1983-01-26
M2000 INTRAPARTUM FETAL MONITOR
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HGM
1983-01-26
M2100 ANTEPARTUM FETAL MONITOR
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HGM
1982-09-30
MEDICAL LABS FETAL SCAN #1000 W/CENTRAL
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HGM
1982-07-26
TELEPHONE LINK DATA TRANSMISSION SYS
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HGM
1982-06-25
FETAL MONITOR #FM 750
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HGM
1982-06-25
CENTRAL DISPLAY SYSTEM #CS400
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HGM
1982-02-12
FETASCAN 2000,2000A OBSTETRICAL DATA
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HGM
1982-01-28
FETASCAN 1000, 1000A OBSTETRICAL DATA
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HGM
1981-12-10
EPCOM EMS-180 ANTEPARTUM FETAL MONITOR
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HGM
1981-11-06
FETASONDE 5, #30, CENTRAL NURSING STAT
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HGM
1981-10-20
MODEL AP 180 MINI-MONITOR
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HGM
1980-08-13
TERUMO FETAL MONITOR # FHM-602
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HGM
1980-03-07
FETAL MONITOR MODEL FHM-1
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HGM
1979-09-04
FETASONDE FETAL HEART RATE VARIABILITY
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HGM
1979-09-04
FETASONDE UTERINE ACTIVITY MONITOR
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HGM
1979-09-04
FETASONDE LABOR STATUS DISPLAY
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HGM
1979-09-04
FETASONDE UTERINE WORK MONITOR
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HGM
1979-09-04
FETASONDE FETAL ACTIVITY MONITOR
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HGM
1979-06-01
FETASONDE MODEL 2108
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HGM
1979-02-16
MONITOR, OFFICE MODEL 140
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HGM
1978-09-26
MODEL 80032A, OBSTETRICAL TELEMETRY
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HGM
1978-09-07
MODEL 80100A, PATIENT DATA MEMORY
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HGM
1978-03-02
FETAL MONITOR MODEL 112
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HGM
1978-03-02
DISPLAY SYSTEM MODEL 428
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HGM
1977-08-25
FETAL MONITORING SYSTEM
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HGM
1977-08-03
FETAL MONITORING SYS. MODEL FM3R
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HGM
1977-08-03
MARKER GENERATOR MODULES - 21597A
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HGM
1977-08-03
FETAL/MATERNAL REPEATER - 21596A
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HGM
1977-08-03
FETAL/MATERNAL ALRM MODULE - 21595A
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HGM
1977-04-26
MONITOR, FETAL, NO. L04-1100
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