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
- K140163KOALA TOCO2Cleared 510(K)
- K061044FEATHERLITE AQUA TOCODYNAMOMETER2Cleared 510(K)
- K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING2Cleared 510(K)
- K013477TOCO LITE, MODEL TD-012Cleared 510(K)
- K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #35652Cleared 510(K)
- K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING2Cleared 510(K)
- K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES2Cleared 510(K)
- K952579TOCO TRANSDUCER2Cleared 510(K)
- K920152BUBBLE TOCO2Cleared 510(K)
- K910282MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER2Cleared 510(K)
- P890063GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)2PMA Approval
- P890063GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.2PMA Approval
- P890063GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.2PMA Approval
- K904691AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST2Cleared 510(K)
- K903623MODEL600 UTERINE ACTIVITY MONITOR2Cleared 510(K)
- K902104ORION WATCHGUARD2Cleared 510(K)
- P890063GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM2PMA Approval
- K894030MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR2Cleared 510(K)
- K893770TERM GUARD II DEVICE2Cleared 510(K)
- K891997CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER2Cleared 510(K)
- K882080MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.2Cleared 510(K)
- K874631HEALTHPHONE TOCO MODEL2Cleared 510(K)
- K873150PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.2Cleared 510(K)
- K860933AIR-CUSHION TOCOTONOMETER2Cleared 510(K)
- K853856EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET2Cleared 510(K)
- K843011TERM GUARD 5000 UTERINE ACTIVITY2Cleared 510(K)
- K840747TOCO DATA TELEPHONE TRANSMITTER DT100P2Cleared 510(K)
- HFNTransducer, Pressure, Intrauterine2Product Code
- HFORecorder, Pressure, Intrauterine2Product Code
- HFPMonitor, Phonocardiographic, Fetal2Product Code
- HGLTransducer, Ultrasonic, Obstetric2Product Code
- HGMSystem, Monitoring, Perinatal2Product Code
- 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
GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- MATRIA HEALTHCARE, INC.
- Trade Name
- GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
- Generic Name
- Monitor, uterine contraction, external (for use in clinic)
- Decision Date
- 9/12/1990
- Days to Decision
- 301 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval