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510(k) Data Aggregation

    K Number
    K132918
    Device Name
    SENSE-4BABY SYSTEM
    Manufacturer
    SENSE4BABY, INC.
    Date Cleared
    2013-11-22

    (66 days)

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

    SENSE4BABY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sense4Baby System Model B+ is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. It is to be used by health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patients' home on the order of a physician.
    Device Description
    The Sense4Baby Model B+ is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine contractions during antepartum (nonstress) testing. The system transmits the measured data to a gateway device, and then a HIPAA-Compliant web based portal for storage and physician review.
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