Panels › Obstetrics/Gynecology › Product code HGM · Class 2
System, Monitoring, Perinatal
Regulation 884.2740
2510(k)s in 12 months (215 all time)
5recalls in 12 months (28 all time)
22recalls that name a 510(k)
Top companies in HGM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 5, 1988 | K882966 | MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM Ge Medical Systems Information Technologies | HGM |
| Jun 10, 1988 | K880419 | MODEL 800 O.B. DATA ARCHIVAL SYSTEM Ge Medical Systems Information Technologies | HGM |
| Aug 4, 1987 | K871082 | FETAL CARE MONITOR ANTEPARTUM 1500 Pie Data Medical BV, NL | HGM |
| Jun 1, 1987 | K871383 | FETALERT ADR FETAL MONITOR Advanced Technology Laboratories, Inc. | HGM |
| May 26, 1987 | K871385 | MODEL U-1000 WITH GESTATIONAL AGE CALCULATION Fukuda Denshi USA, Inc. | HGM |
| May 4, 1987 | K870692 | PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085 Peritronics Research and Development, Inc. | HGM |
| Sep 5, 1986 | K860237 | OMF-7101 FETAL MONITOR Nihon Kohden America, Inc. | HGM |
| Jul 18, 1986 | K861544 | MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM Hewlett-Packard Co., DE | HGM |
| Jul 7, 1986 | K861556 | MODIFIED FETAL MONITOR MODEL FM-2 Advantage Medical Systems, Inc. | HGM |
| May 30, 1986 | K861455 | MODEL DT-102 DATA TELEPHONE TRANSMITTER Advantage Medical Systems, Inc. | HGM |
| May 19, 1986 | K860295 | FETASCAN 1500 International Biomedics, Inc. | HGM |
| Apr 8, 1986 | K861189 | TECNOL SECURE-ALL FETAL MONITOR STRAP Tecnol New Jersey Wound Care, Inc. | HGM |
| Mar 12, 1986 | K855044 | PERINATAL COMPUTER SYS MODEL 100A & 100B Peritronics Research and Development, Inc. | HGM |
| Nov 26, 1985 | K852704 | TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT Clincal Instruments Corp. | HGM |
| Sep 27, 1985 | K852608 | SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM Ge Medical Systems Information Technologies | HGM |
| Sep 20, 1985 | K842422 | KONTRON FAX FETAL MONITOR Kontron Instruments, Inc. | HGM |
| Jul 5, 1985 | K852518 | MODIFICATION FETAL MONITOR MODEL FM-2 Advantage Medical Systems, Inc. | HGM |
| Jul 5, 1985 | K852076 | MODEL 145 FETAL MONITOR Ge Medical Systems Information Technologies | HGM |
| May 22, 1985 | K851252 | COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME Ge Medical Systems Information Technologies | HGM |
| May 1, 1985 | K844724 | FETAL TELEMETRY SYSTEM Advantage Medical Systems, Inc. | HGM |
| Dec 17, 1984 | K843918 | COROMETRICS FETAL MONITOR 142 Ge Medical Systems Information Technologies | HGM |
| Nov 29, 1984 | K843385 | COROMETRICS 115 FETAL MONITOR Ge Medical Systems Information Technologies | HGM |
| May 14, 1984 | K841477 | COROMETRICS 815 FETAL ECG RECORDER Ge Medical Systems Information Technologies | HGM |
| Oct 4, 1983 | K832849 | FETAL MONITOR #FM-2 Advantage Medical Systems, Inc. | HGM |
| Aug 12, 1983 | K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE Epcom Medical Systems, Inc. | HGM |
| Aug 12, 1983 | K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET Epcom Medical Systems, Inc. | HGM |
| Aug 12, 1983 | K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR Epcom Medical Systems, Inc. | HGM |
| Aug 11, 1983 | K831852 | FETAL MONITOR #115 Ge Medical Systems Information Technologies | HGM |
| Jun 30, 1983 | K831371 | MODEL FM5 Sonicaid, Inc. | HGM |
| Jan 26, 1983 | K823188 | M2000 INTRAPARTUM FETAL MONITOR Huntleigh Technology, Inc. | HGM |
| Jan 26, 1983 | K823081 | M2100 ANTEPARTUM FETAL MONITOR Huntleigh Technology, Inc. | HGM |
| Sep 30, 1982 | K822830 | MEDICAL LABS FETAL SCAN #1000 W/CENTRAL Cranbury Medical Labs, Inc. | HGM |
| Jul 26, 1982 | K821478 | TELEPHONE LINK DATA TRANSMISSION SYS Advantage Medical Systems, Inc. | HGM |
| Jun 25, 1982 | K821580 | FETAL MONITOR #FM 750 Advantage Medical Systems, Inc. | HGM |
| Jun 25, 1982 | K821479 | CENTRAL DISPLAY SYSTEM #CS400 Advantage Medical Systems, Inc. | HGM |
| Feb 12, 1982 | K813457 | FETASCAN 2000,2000A OBSTETRICAL DATA Cranbury Medical Labs, Inc. | HGM |
| Jan 28, 1982 | K813458 | FETASCAN 1000, 1000A OBSTETRICAL DATA Cranbury Medical Labs, Inc. | HGM |
| Dec 10, 1981 | K813007 | EPCOM EMS-180 ANTEPARTUM FETAL MONITOR Epcom Medical Systems, Inc. | HGM |
| Nov 6, 1981 | K812863 | FETASONDE 5, #30, CENTRAL NURSING STAT Kontron Instruments, Inc. | HGM |
| Oct 20, 1981 | K812256 | MODEL AP 180 MINI-MONITOR Sonicaid, Inc. | HGM |
| Aug 13, 1980 | K801747 | TERUMO FETAL MONITOR # FHM-602 Terumo Medical Corp. | HGM |
| Mar 7, 1980 | K800013 | FETAL MONITOR MODEL FHM-1 Advantage Medical Systems, Inc. | HGM |
| Sep 4, 1979 | K791039 | FETASONDE FETAL HEART RATE VARIABILITY Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791038 | FETASONDE UTERINE ACTIVITY MONITOR Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791037 | FETASONDE LABOR STATUS DISPLAY Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791036 | FETASONDE UTERINE WORK MONITOR Roche Medical Electronics, Inc. | HGM |
| Sep 4, 1979 | K791035 | FETASONDE FETAL ACTIVITY MONITOR Roche Medical Electronics, Inc. | HGM |
| Jun 1, 1979 | K790761 | FETASONDE MODEL 2108 Roche Medical Electronics, Inc. | HGM |
| Feb 16, 1979 | K790139 | MONITOR, OFFICE MODEL 140 Ge Medical Systems Information Technologies | HGM |
| Sep 26, 1978 | K781359 | MODEL 80032A, OBSTETRICAL TELEMETRY Hewlett-Packard Co. | HGM |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.