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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993008 | QUANTITATIVE SENTINEL SYSTEM | Marquette Medical Systems, Inc. | 1999-12-06 | Traditional | PDF ↗ |
| K991905 | COROMETRICS MODEL 171 AND 172 FETAL MONITOR | General Electric Medical Systems Information Techn | 1999-09-01 | Traditional | PDF ↗ |
| K991739 | COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR | General Electric Medical Systems Information Techn | 1999-08-19 | Traditional | PDF ↗ |
| K983395 | FETALGARD 3000 FETAL MONITOR | Analogic Corp. | 1999-08-12 | Traditional | PDF ↗ |
| K974248 | WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM | Air-Shields, Inc. | 1998-10-07 | Traditional | PDF ↗ |
| K980719 | CALM | Lms Medical Systems , Ltd. | 1998-07-31 | Traditional | PDF ↗ |
| K965008 | BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM | Spacelabs Medical, Inc. | 1997-12-16 | Traditional | PDF ↗ |
| K970456 | HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM | Hewlett-Packard GmbH | 1997-10-03 | Traditional | PDF ↗ |
| K963711 | BABY DOPPLEX (3000) | Huntleigh Healthcare, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K971099 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169 | Alexander Mfg. Co. | 1997-06-05 | Traditional | PDF ↗ |
| K960553 | CARD GUARD MODEL CG-900 | Card Guard Scientific Survival , Ltd. | 1997-04-22 | Traditional | PDF ↗ |
| K963608 | QUANTITATIVE SENTINEL SYSTEM | Quantitative Medicine, Inc. | 1997-03-11 | Traditional | PDF ↗ |
| K964770 | COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR | Ge Medical Systems Information Technologies | 1997-02-21 | Traditional | PDF ↗ |
| K955931 | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) | Advanced Medical Systems, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K960109 | QUANTITATIVE SENTINEL SYSTEM | Quantitative Medicine, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K954351 | SERIES 50XM | Hewlett-Packard GmbH | 1996-03-08 | Traditional | PDF ↗ |
| K955559 | COROMETRICS FETAL MOVEMENT DETECTION KIT | Ge Medical Systems Information Technologies | 1996-03-05 | Traditional | PDF ↗ |
| K950420 | FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 | Analogic Corp. | 1995-05-15 | Traditional | PDF ↗ |
| K931133 | CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP | Clinicomp, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K940898 | MODEL IM77 INTRAPARTUM FETAL MONITOR | Advanced Medical Systems, Inc. | 1995-03-01 | Traditional | PDF ↗ |
| K935301 | R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050 | R & D Batteries, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K935377 | R AND D BATTERIES | R & D Batteries, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K934959 | MODEL 118 FETAL/MATERNAL MONITOR | Ge Medical Systems Information Technologies | 1994-08-15 | Traditional | PDF ↗ |
| K942887 | MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM | Hewlett-Packard Co. | 1994-08-15 | Traditional | PDF ↗ |
| K932077 | MODEL 151 FETAL MONITOR | Ge Medical Systems Information Technologies | 1994-03-31 | Traditional | PDF ↗ |
| K925572 | MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE | Neward Enterprises, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K921957 | HEWLETT-PACKARD MODEL M1351A FETAL MONITOR | Hewlett-Packard Co. | 1993-09-24 | Traditional | PDF ↗ |
| K921956 | HEWLETT PACKARD MODEL M1353A FETAL MONITOR | Hewlett-Packard Co. | 1993-09-24 | Traditional | PDF ↗ |
| K920376 | COROMETRICS MODEL 150 FETAL MONITOR | Ge Medical Systems Information Technologies | 1992-04-27 | Traditional | PDF ↗ |
| K912138 | HOMEVUE MONITORING SYS.MODEL TD 2000 | Homevue Health Systems, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K912890 | MODEL SONICAID AXIS | Oxford Medilog, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K912639 | SONICAID TEAM | Oxford Medilog, Inc. | 1991-12-31 | Traditional | PDF ↗ |
| K910169 | FETALGARD 2000 | Analogic Corp. | 1991-07-22 | Traditional | PDF ↗ |
| K910418 | LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 | Graphic Controls Corp. | 1991-07-16 | Traditional | PDF ↗ |
| K910260 | COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST | Ge Medical Systems Information Technologies | 1991-03-15 | Traditional | PDF ↗ |
| K905606 | EXTERNAL FETAL MONITOR TRANSDUCER HOLDER | Atheus Corp. | 1991-03-12 | Traditional | PDF ↗ |
| K905295 | CATALOG NUMBER 2609 LEG PLATE | Ge Medical Systems Information Technologies | 1991-02-19 | Traditional | PDF ↗ |
| K902690 | SONICAID MODEL MERIDIAN 800 | Oxford Medilog, Inc. | 1991-02-05 | Traditional | PDF ↗ |
| K903992 | CYGNET CENTRAL | Cygnet Co., Inc. | 1990-12-19 | Traditional | PDF ↗ |
| K904358 | MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL | Ge Medical Systems Information Technologies | 1990-10-05 | Traditional | PDF ↗ |
| K902802 | FETAL MONITORING TRANSDUCER STRAP | Macon & Co., Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K900480 | M1350A FETAL MONITOR (INTRAPARTUM) | Hewlett-Packard Co. | 1990-07-02 | Traditional | PDF ↗ |
| K893981 | WATCHCHILD | Monox, Inc. | 1990-04-20 | Traditional | PDF ↗ |
| K895045 | MODEL 410T TELECOMMUNICATION SYSTEM | Ge Medical Systems Information Technologies | 1989-11-06 | Traditional | PDF ↗ |
| K894036 | TOITU FETAL ACTOCARDIOGRAPH, MT-332 | Toitu of America, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K894958 | MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM | Ge Medical Systems Information Technologies | 1989-11-03 | Traditional | PDF ↗ |
| K892501 | WRIGHT MEDICAL FETASAFE | Wright Medical Corp. | 1989-09-12 | Traditional | PDF ↗ |
| K892354 | ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A | Hewlett-Packard Co. | 1989-08-08 | Traditional | PDF ↗ |
| K891595 | MODEL 116 FETAL MONITOR | Ge Medical Systems Information Technologies | 1989-06-12 | Traditional | PDF ↗ |
| K882084 | GENESIS TM FETAL SYSTEM | Pediatric Diagnostic Service | 1989-05-26 | Traditional | PDF ↗ |
| K882966 | MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM | Ge Medical Systems Information Technologies | 1988-10-05 | Traditional | PDF ↗ |
| K880419 | MODEL 800 O.B. DATA ARCHIVAL SYSTEM | Ge Medical Systems Information Technologies | 1988-06-10 | Traditional | PDF ↗ |
| K871082 | FETAL CARE MONITOR ANTEPARTUM 1500 | Pie Data Medical BV | 1987-08-04 | Traditional | PDF ↗ |
| K871383 | FETALERT ADR FETAL MONITOR | Advanced Technology Laboratories, Inc. | 1987-06-01 | Traditional | PDF ↗ |
| K871385 | MODEL U-1000 WITH GESTATIONAL AGE CALCULATION | Fukuda Denshi USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870692 | PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085 | Peritronics Research and Development, Inc. | 1987-05-04 | Traditional | PDF ↗ |
| K860237 | OMF-7101 FETAL MONITOR | Nihon Kohden America, Inc. | 1986-09-05 | Traditional | PDF ↗ |
| K861544 | MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM | Hewlett-Packard Co. | 1986-07-18 | Traditional | PDF ↗ |
| K861556 | MODIFIED FETAL MONITOR MODEL FM-2 | Advantage Medical Systems, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K861455 | MODEL DT-102 DATA TELEPHONE TRANSMITTER | Advantage Medical Systems, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K860295 | FETASCAN 1500 | International Biomedics, Inc. | 1986-05-19 | Traditional | PDF ↗ |
| K861189 | TECNOL SECURE-ALL FETAL MONITOR STRAP | Tecnol New Jersey Wound Care, Inc. | 1986-04-08 | Traditional | PDF ↗ |
| K855044 | PERINATAL COMPUTER SYS MODEL 100A & 100B | Peritronics Research and Development, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K852704 | TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT | Clincal Instruments Corp. | 1985-11-26 | Traditional | PDF ↗ |
| K852608 | SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM | Ge Medical Systems Information Technologies | 1985-09-27 | Traditional | PDF ↗ |
| K842422 | KONTRON FAX FETAL MONITOR | Kontron Instruments, Inc. | 1985-09-20 | Traditional | PDF ↗ |
| K852518 | MODIFICATION FETAL MONITOR MODEL FM-2 | Advantage Medical Systems, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K852076 | MODEL 145 FETAL MONITOR | Ge Medical Systems Information Technologies | 1985-07-05 | Traditional | PDF ↗ |
| K851252 | COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME | Ge Medical Systems Information Technologies | 1985-05-22 | Traditional | PDF ↗ |
| K844724 | FETAL TELEMETRY SYSTEM | Advantage Medical Systems, Inc. | 1985-05-01 | Traditional | PDF ↗ |
| K843918 | COROMETRICS FETAL MONITOR 142 | Ge Medical Systems Information Technologies | 1984-12-17 | Traditional | PDF ↗ |
| K843385 | COROMETRICS 115 FETAL MONITOR | Ge Medical Systems Information Technologies | 1984-11-29 | Traditional | PDF ↗ |
| K841477 | COROMETRICS 815 FETAL ECG RECORDER | Ge Medical Systems Information Technologies | 1984-05-14 | Traditional | PDF ↗ |
| K832849 | FETAL MONITOR #FM-2 | Advantage Medical Systems, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET | Epcom Medical Systems, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR | Epcom Medical Systems, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE | Epcom Medical Systems, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831852 | FETAL MONITOR #115 | Ge Medical Systems Information Technologies | 1983-08-11 | Traditional | PDF ↗ |
| K831371 | MODEL FM5 | Sonicaid, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K823081 | M2100 ANTEPARTUM FETAL MONITOR | Huntleigh Technology, Inc. | 1983-01-26 | Traditional | PDF ↗ |
| K823188 | M2000 INTRAPARTUM FETAL MONITOR | Huntleigh Technology, Inc. | 1983-01-26 | Traditional | PDF ↗ |
| K822830 | MEDICAL LABS FETAL SCAN #1000 W/CENTRAL | Cranbury Medical Labs, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821478 | TELEPHONE LINK DATA TRANSMISSION SYS | Advantage Medical Systems, Inc. | 1982-07-26 | Traditional | PDF ↗ |
| K821580 | FETAL MONITOR #FM 750 | Advantage Medical Systems, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K821479 | CENTRAL DISPLAY SYSTEM #CS400 | Advantage Medical Systems, Inc. | 1982-06-25 | Traditional | PDF ↗ |
| K813457 | FETASCAN 2000,2000A OBSTETRICAL DATA | Cranbury Medical Labs, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K813458 | FETASCAN 1000, 1000A OBSTETRICAL DATA | Cranbury Medical Labs, Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K813007 | EPCOM EMS-180 ANTEPARTUM FETAL MONITOR | Epcom Medical Systems, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K812863 | FETASONDE 5, #30, CENTRAL NURSING STAT | Kontron Instruments, Inc. | 1981-11-06 | Traditional | PDF ↗ |
| K812256 | MODEL AP 180 MINI-MONITOR | Sonicaid, Inc. | 1981-10-20 | Traditional | PDF ↗ |
| K801747 | TERUMO FETAL MONITOR # FHM-602 | Terumo Medical Corp. | 1980-08-13 | Traditional | PDF ↗ |
| K800013 | FETAL MONITOR MODEL FHM-1 | Advantage Medical Systems, Inc. | 1980-03-07 | Traditional | PDF ↗ |
| K791037 | FETASONDE LABOR STATUS DISPLAY | Roche Medical Electronics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791038 | FETASONDE UTERINE ACTIVITY MONITOR | Roche Medical Electronics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791035 | FETASONDE FETAL ACTIVITY MONITOR | Roche Medical Electronics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791036 | FETASONDE UTERINE WORK MONITOR | Roche Medical Electronics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791039 | FETASONDE FETAL HEART RATE VARIABILITY | Roche Medical Electronics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K790761 | FETASONDE MODEL 2108 | Roche Medical Electronics, Inc. | 1979-06-01 | Traditional | PDF ↗ |
| K790139 | MONITOR, OFFICE MODEL 140 | Ge Medical Systems Information Technologies | 1979-02-16 | Traditional | PDF ↗ |
| K781359 | MODEL 80032A, OBSTETRICAL TELEMETRY | Hewlett-Packard Co. | 1978-09-26 | Traditional | PDF ↗ |
Product code HGM · Class II · Obstetrics/Gynecology. Data: openFDA.