Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- HEQMonitor, Pressure, Arterial, Fetal, Ultrasonic2Product Code
- HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic2Product Code
- HEJMonitor, Hemic Sound, Ultrasonic2Product Code
- HEKMonitor, Heart Sound, Fetal, Ultrasonic2Product Code
- HELMonitor, Heart Rate, Fetal, Ultrasonic2Product Code
- HEMImager, Ultrasonic Obstetric-Gynecologic2Product Code
- HENCaliper, Fetal Head, Ultrasonic2Product Code
- HEOAnalyzer, Data, Obstetric3Product Code
- HEPMonitor, Blood-Flow, Ultrasonic2Product Code
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)2Product Code
- HFNTransducer, Pressure, Intrauterine2Product Code
- HFORecorder, Pressure, Intrauterine2Product Code
- HFPMonitor, Phonocardiographic, Fetal2Product Code
- HGLTransducer, Ultrasonic, Obstetric2Product Code
- HGMSystem, Monitoring, Perinatal2Product Code
- K250777Sonicaid Team32Cleared 510(K)
- K241882Fetal & Maternal Monitor (F15A, F15A Air)2Cleared 510(K)
- K241368Sonicaid Team32Cleared 510(K)
- K241009PeriCALM Patterns 3.02Cleared 510(K)
- K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)2Cleared 510(K)
- K231964Novii+ Wireless Patch System2Cleared 510(K)
- K222327Bloomlife MFM-Pro2Cleared 510(K)
- K220732Mural Perinatal Surveillance2Cleared 510(K)
- K200975Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum2Cleared 510(K)
- K173941IntelliSpace Perinatal Rev.K.002Cleared 510(K)
- K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F32Cleared 510(K)
- K173715AlertWatch:OB2Cleared 510(K)
- K171178Central Monitoring System2Cleared 510(K)
- K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring2Cleared 510(K)
- K161902Meridian M110 Fetal Monitoring System2Cleared 510(K)
- K153580Central Monitoring System2Cleared 510(K)
- K150398EUM 100Pro2Cleared 510(K)
- K142799Model BT-220L and BT-220C2Cleared 510(K)
- K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express2Cleared 510(K)
- K142883MindChild Meridian M100 Fetal Heart Rate Monitor2Cleared 510(K)
- K143695CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K140535PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM502Cleared 510(K)
- K141194FM-3000 FETAL MONITOR2Cleared 510(K)
- K131941FETAL MONITORS2Cleared 510(K)
- K132650SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM2Cleared 510(K)
- K132918SENSE-4BABY SYSTEM2Cleared 510(K)
- K123335SUNRAY FETAL MONITOR2Cleared 510(K)
- K121758CERNER FETALINK+(VERSION1.0)2Cleared 510(K)
- K120018MINDCHILD MERIDIAN FETAL HEART RATE MONITOR2Cleared 510(K)
- K121267BT-200V VASCULAR DOPPLER2Cleared 510(K)
- K121208OBIX PERINATAL DATA SYSTEM 7.02Cleared 510(K)
- K112317FM-9000 PLUS FETAL AND MATERNAL MONITOR2Cleared 510(K)
- K110612FM202Cleared 510(K)
- K111614CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE2Cleared 510(K)
- K112187FM-1000 PLUS FETAL MONITOR2Cleared 510(K)
- K112159CMS-1000FM CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K111083PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM502Cleared 510(K)
- K110556MINI TELEMETRY SYSTEM2Cleared 510(K)
- K103545BT-3502Cleared 510(K)
- K102263HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.02Cleared 510(K)
- K102958PHILIPS AVALON FETAL MONITOR2Cleared 510(K)
- K103172CIV-OB (PLUS)2Cleared 510(K)
- K102140FETAL MONITORS, MODELS F2 AND F32Cleared 510(K)
- K100358CENTRAL MONITORING SYSTEM2Cleared 510(K)
- K100797FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS2Cleared 510(K)
- K100420PHILIPS OBTRACEVUE MODEL SW REV. G.002Cleared 510(K)
- K100885FETAL MONITOR MODEL: BT-200T2Cleared 510(K)
- K092028PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM502Cleared 510(K)
- K091251CERNER FETALINK (VERSION 1.0)2Cleared 510(K)
- K090285SONICAID FM820 AND FM830 ENCORE2Cleared 510(K)
- K090269AIRSTRIP OB2Cleared 510(K)
- K090061AIRSTRIP OB2Cleared 510(K)
- K082602FETAL & MATERNAL MONITOR, MODEL F6, F92Cleared 510(K)
- K082369CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR2Cleared 510(K)
- K081203OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.002Cleared 510(K)
- K080226NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P29122Cleared 510(K)
- K073221CADENCE II2Cleared 510(K)
- K072976MODEL 250CX SERIES MATERNAL/FETAL MONITOR2Cleared 510(K)
- K071800PHILIPS AVALON FETAL MONITORS FM20 AND FM302Cleared 510(K)
- K062137MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM302Cleared 510(K)
- K050826FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS2Cleared 510(K)
- K060230DOPPLEX CENTRALE2Cleared 510(K)
- K051175CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION2Cleared 510(K)
- K052795PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM302Cleared 510(K)
- K052715CALM CURVE, VERSION 01.002Cleared 510(K)
- K043597FC 700 FETAL MONITOR2Cleared 510(K)
- K043598FC 1400 FETAL MONITOR2Cleared 510(K)
- K052190FETAL MONITOR, MODELS BT-300 AND BT-2002Cleared 510(K)
- K050234REMOTE CARE2Cleared 510(K)
- K043075TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING2Cleared 510(K)
- K050583MODEL 250 SERIES MATERNAL/FETAL MONITOR2Cleared 510(K)
- K040788CALM PATTERNS, VERSION 01.00.002Cleared 510(K)
- K042082AIRSTRIP OB2Cleared 510(K)
- K040903CADENCE, MODELS 2001 AND 20022Cleared 510(K)
- K040819TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM108342Cleared 510(K)
- K032772MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM2Cleared 510(K)
- K032252MODEL 120 SERIES MATERNAL/FETAL MONITOR2Cleared 510(K)
- K030261BATTERY, RECHARGEABLE2Cleared 510(K)
- K023931PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A2Cleared 510(K)
- K023618SONICAID ONE2Cleared 510(K)
- K021574TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER2Cleared 510(K)
- K021135MODEL 2120IS SERIES MATERNAL/FETAL MONITOR2Cleared 510(K)
- K013281VERSALAB APM2Cleared 510(K)
- K014094MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K012718MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.2Cleared 510(K)
- K011304OB-1 FETAL MONITOR2Cleared 510(K)
- K010552CG-900P FETAL/MATERNAL MONITOR2Cleared 510(K)
- K992607SONICAID SYSTEM 80022Cleared 510(K)
- K010894BABY DOPPLEX 3002 (BD3002)2Cleared 510(K)
- K010889BABY DOPPLEX 3000 MK 2 (BD3000)2Cleared 510(K)
- K002150SONICAID FM820, SONICAID FM8302Cleared 510(K)
- K002548FETAL ASSIST2Cleared 510(K)
- K002503FETALGARD LITE2Cleared 510(K)
- K994008BIOSYS FETAL MONITOR, MODEL IFM-5002Cleared 510(K)
- K001882BABY DOPPLEX 4002-TWINS, MODEL BD40022Cleared 510(K)
- K001677BABY DOPPLEX 4000 (BD4000)2Cleared 510(K)
- K993751COROMETRICS MODEL 173 FETAL MONITOR2Cleared 510(K)
- K990569BABY DOPPLEX 4000, MODEL BD 40002Cleared 510(K)
- K993008QUANTITATIVE SENTINEL SYSTEM2Cleared 510(K)
- K991905COROMETRICS MODEL 171 AND 172 FETAL MONITOR2Cleared 510(K)
- K991739COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR2Cleared 510(K)
- K983395FETALGARD 3000 FETAL MONITOR2Cleared 510(K)
- K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K980719CALM2Cleared 510(K)
- K965008BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K970456HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM2Cleared 510(K)
- K963711BABY DOPPLEX (3000)2Cleared 510(K)
- K971099ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS51692Cleared 510(K)
- K960553CARD GUARD MODEL CG-9002Cleared 510(K)
- K963608QUANTITATIVE SENTINEL SYSTEM2Cleared 510(K)
- K964770COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR2Cleared 510(K)
- K955931MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)2Cleared 510(K)
- K960109QUANTITATIVE SENTINEL SYSTEM2Cleared 510(K)
- K954351SERIES 50XM2Cleared 510(K)
- K955559COROMETRICS FETAL MOVEMENT DETECTION KIT2Cleared 510(K)
- K950420FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP32Cleared 510(K)
- K931133CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISP2Cleared 510(K)
- K940898MODEL IM77 INTRAPARTUM FETAL MONITOR2Cleared 510(K)
- K935377R AND D BATTERIES2Cleared 510(K)
- K935301R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 50502Cleared 510(K)
- K942887MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM2Cleared 510(K)
- K934959MODEL 118 FETAL/MATERNAL MONITOR2Cleared 510(K)
- K932077MODEL 151 FETAL MONITOR2Cleared 510(K)
- K925572MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE2Cleared 510(K)
- K921957HEWLETT-PACKARD MODEL M1351A FETAL MONITOR2Cleared 510(K)
- K921956HEWLETT PACKARD MODEL M1353A FETAL MONITOR2Cleared 510(K)
- K920376COROMETRICS MODEL 150 FETAL MONITOR2Cleared 510(K)
- K912138HOMEVUE MONITORING SYS.MODEL TD 20002Cleared 510(K)
- K912890MODEL SONICAID AXIS2Cleared 510(K)
- K912639SONICAID TEAM2Cleared 510(K)
- K910169FETALGARD 20002Cleared 510(K)
- K910418LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-1002Cleared 510(K)
- K910260COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST2Cleared 510(K)
- K905606EXTERNAL FETAL MONITOR TRANSDUCER HOLDER2Cleared 510(K)
- K905295CATALOG NUMBER 2609 LEG PLATE2Cleared 510(K)
- K902690SONICAID MODEL MERIDIAN 8002Cleared 510(K)
- K903992CYGNET CENTRAL2Cleared 510(K)
- K904358MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL2Cleared 510(K)
- K902802FETAL MONITORING TRANSDUCER STRAP2Cleared 510(K)
- K900480M1350A FETAL MONITOR (INTRAPARTUM)2Cleared 510(K)
- K893981WATCHCHILD2Cleared 510(K)
- K895045MODEL 410T TELECOMMUNICATION SYSTEM2Cleared 510(K)
- K894036TOITU FETAL ACTOCARDIOGRAPH, MT-3322Cleared 510(K)
- K894958MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM2Cleared 510(K)
- K892501WRIGHT MEDICAL FETASAFE2Cleared 510(K)
- K892354ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A2Cleared 510(K)
- K891595MODEL 116 FETAL MONITOR2Cleared 510(K)
- K882084GENESIS TM FETAL SYSTEM2Cleared 510(K)
- K882966MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM2Cleared 510(K)
- K880419MODEL 800 O.B. DATA ARCHIVAL SYSTEM2Cleared 510(K)
- K871082FETAL CARE MONITOR ANTEPARTUM 15002Cleared 510(K)
- K871383FETALERT ADR FETAL MONITOR2Cleared 510(K)
- K871385MODEL U-1000 WITH GESTATIONAL AGE CALCULATION2Cleared 510(K)
- K870692PERINATAL COMPUTERS 2015/2025/2040/2045/2080/20852Cleared 510(K)
- K860237OMF-7101 FETAL MONITOR2Cleared 510(K)
- K861544MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM2Cleared 510(K)
- K861556MODIFIED FETAL MONITOR MODEL FM-22Cleared 510(K)
- K861455MODEL DT-102 DATA TELEPHONE TRANSMITTER2Cleared 510(K)
- K860295FETASCAN 15002Cleared 510(K)
- K861189TECNOL SECURE-ALL FETAL MONITOR STRAP2Cleared 510(K)
- K855044PERINATAL COMPUTER SYS MODEL 100A & 100B2Cleared 510(K)
- K852704TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT2Cleared 510(K)
- K852608SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM2Cleared 510(K)
- K842422KONTRON FAX FETAL MONITOR2Cleared 510(K)
- K852518MODIFICATION FETAL MONITOR MODEL FM-22Cleared 510(K)
- K852076MODEL 145 FETAL MONITOR2Cleared 510(K)
- K851252COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME2Cleared 510(K)
- K844724FETAL TELEMETRY SYSTEM2Cleared 510(K)
- K843918COROMETRICS FETAL MONITOR 1422Cleared 510(K)
- K843385COROMETRICS 115 FETAL MONITOR2Cleared 510(K)
- K841477COROMETRICS 815 FETAL ECG RECORDER2Cleared 510(K)
- K832849FETAL MONITOR #FM-22Cleared 510(K)
- K831115EPCOM EMS-320 REMOTE MONITORSCOPE2Cleared 510(K)
- K831114EPCOM EMS-330 FREEDOM I TELEDOP OBSTET2Cleared 510(K)
- K831113EPCOM EMS-310 INTRAPARTUM MONITOR2Cleared 510(K)
- K831852FETAL MONITOR #1152Cleared 510(K)
- K831371MODEL FM52Cleared 510(K)
- K823188M2000 INTRAPARTUM FETAL MONITOR2Cleared 510(K)
- K823081M2100 ANTEPARTUM FETAL MONITOR2Cleared 510(K)
- K822830MEDICAL LABS FETAL SCAN #1000 W/CENTRAL2Cleared 510(K)
- K821478TELEPHONE LINK DATA TRANSMISSION SYS2Cleared 510(K)
- K821580FETAL MONITOR #FM 7502Cleared 510(K)
- K821479CENTRAL DISPLAY SYSTEM #CS4002Cleared 510(K)
- K813457FETASCAN 2000,2000A OBSTETRICAL DATA2Cleared 510(K)
- K813458FETASCAN 1000, 1000A OBSTETRICAL DATA2Cleared 510(K)
- K813007EPCOM EMS-180 ANTEPARTUM FETAL MONITOR2Cleared 510(K)
- K812863FETASONDE 5, #30, CENTRAL NURSING STAT2Cleared 510(K)
- K812256MODEL AP 180 MINI-MONITOR2Cleared 510(K)
- K801747TERUMO FETAL MONITOR # FHM-6022Cleared 510(K)
- K800013FETAL MONITOR MODEL FHM-12Cleared 510(K)
- K791036FETASONDE UTERINE WORK MONITOR2Cleared 510(K)
- K791039FETASONDE FETAL HEART RATE VARIABILITY2Cleared 510(K)
- K791038FETASONDE UTERINE ACTIVITY MONITOR2Cleared 510(K)
- K791037FETASONDE LABOR STATUS DISPLAY2Cleared 510(K)
- K791035FETASONDE FETAL ACTIVITY MONITOR2Cleared 510(K)
- K790761FETASONDE MODEL 21082Cleared 510(K)
- K790139MONITOR, OFFICE MODEL 1402Cleared 510(K)
- K781359MODEL 80032A, OBSTETRICAL TELEMETRY2Cleared 510(K)
- K781360MODEL 80100A, PATIENT DATA MEMORY2Cleared 510(K)
- K780177FETAL MONITOR MODEL 1122Cleared 510(K)
- K780176DISPLAY SYSTEM MODEL 4282Cleared 510(K)
- K771541FETAL MONITORING SYSTEM2Cleared 510(K)
- K771379FETAL MONITORING SYS. MODEL FM3R2Cleared 510(K)
- K771194FETAL/MATERNAL ALRM MODULE - 21595A2Cleared 510(K)
- K771196MARKER GENERATOR MODULES - 21597A2Cleared 510(K)
- K771195FETAL/MATERNAL REPEATER - 21596A2Cleared 510(K)
- K770692MONITOR, FETAL, NO. L04-11002Cleared 510(K)
- K770297FETAL MONITOR, PART #100-110092Cleared 510(K)
- K770296FETAL MONITOR, PART #101-110092Cleared 510(K)
- K761201ECHO-CARDIOTRACE, AUTOMATIC2Cleared 510(K)
- K761139T-M (TIME-MOTION) OPTION2Cleared 510(K)
- K761030EKOSECTOR I2Cleared 510(K)
- K760919MODEL 2106 FETA SONDE FETAL MONITOR2Cleared 510(K)
- HGNStethoscope, Fetal1Product Code
- HGOMonitor, Electroencephalographic, Fetal (And Accessories)3Product Code
- HGPElectrode, Circular (Spiral), Scalp And Applicator2Product Code
- HGSCatheter, Intrauterine And Introducer2Product Code
- HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic2Product Code
- HHXHolograph, Fetal, Acoustical2Product Code
- HIQElectrode, Clip, Fetal Scalp (And Applicator)3Product Code
- KNGMonitor, Ultrasonic, Fetal2Product Code
- KXNMonitor, Cardiac, Fetal2Product Code
- KXOMonitor, Pressure, Intrauterine2Product Code
- LQKHome Uterine Activity Monitor2Product Code
- MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)2Product Code
- NHMSheet, Recording, Breast Examination2Product Code
- NKASystem, Documentation, Breast Lesion2Product Code
- OSPUterine Electromyographic Monitor2Product Code
- NPBSystem, Monitoring, For Progress Of Labor2Product Code
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K852608
- 510(k) Type
- Traditional
- Applicant
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/27/1985
- Days to Decision
- 100 days