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510(k) Data Aggregation

    K Number
    K161902
    Device Name
    Meridian M110 Fetal Monitoring System
    Manufacturer
    Date Cleared
    2017-01-12

    (185 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINDCHILD MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor. The Meridian M110 Fetal Monitoring System is indicated for use on women who are at ≥ 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The Meridian M110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.
    Device Description
    The Meridian M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.
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    K Number
    K142883
    Device Name
    MindChild Meridian M100 Fetal Heart Rate Monitor
    Manufacturer
    Date Cleared
    2015-04-17

    (197 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mindchild Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MindChild Medical Meridian M100 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor. The MindChild Meridian M100 is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The MindChild Meridian is intended for use by healthcare professionals in a clinical setting.
    Device Description
    The Meridian M100 Fetal Heart Rate Monitor is a modification of the cleared M1000 Fetal Heart Rate Monitor (K120018). The modifications are ones that do not affect the intended use or the fundamental scientific technology. The M100 Fetal Heart Rate Monitor is an AC powered fetal heart rate (FHR) monitor. The product consists of a signal processor containing hardware circuitry and software which acquires and processes analog signals using external, abdominal electrode sensors. Software algorithms extract ECG morphology and monitor fetal heart rate. The M100 connects to existing cleared fetal heart rate monitors with DECG (i.e., primary monitor) using the primary monitor's screen for display of fetal heart rate. The patient data is displayed real time on the primary monitor's display. The Meridian M100 is used as an accessory to a main/primary fetal monitor replacing the Doppler sensor on those monitors. The M100 is for use with the GE Corometrics 120 and the GE Corometrics 250 Fetal Monitors.
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    K Number
    K120018
    Device Name
    MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
    Manufacturer
    Date Cleared
    2012-09-19

    (260 days)

    Product Code
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINDCHILD MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode. The MindChild Meridian is indicated for use on women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The MindChild Meridian is intended for use by healthcare professionals in a clinical setting.
    Device Description
    The MindChild Medical Meridian Fetal Heart Rate Monitor is an AC powered fetal heart rate (FHR) monitor. The product consists of a signal processor containing hardware circuitry and software which acquires and processes analog signals using external, abdominal electrode sensors. Software algorithms extract ECG morphology and monitor fetal heart rate. Data is stored locally for retrieval in an off-line mode. The patient data is displayed real time on a touch screen LCD display monitor. Data may be printed out offline for permanent hard copy records. The system also possesses the ability to acquire and analyze signals from a fetal scalp electrode using the device's direct ECG (DECG) capability. The entire system is housed within a medical grade roll-up cart. The device is intended to be used in a hospital environment by trained medical staff. The MindChild Medical Meridian Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally or internally measures and displays fetal heart rate (FHR). The MindChild Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The MindChild Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a fetal scalp electrode.
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