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510(k) Data Aggregation

    K Number
    K020390
    Device Name
    MODIFICATION TO FETAL ASSIST
    Manufacturer
    HUNTLEIGH DIAGNOSTICS LTD.
    Date Cleared
    2002-04-19

    (72 days)

    Product Code
    LQK
    Regulation Number
    884.2730
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUNTLEIGH DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications. The FETAL ASSIST is specifically intended for use in the following specific areas: - antenatal monitoring in the hospital, doctors office, health clinic, home or community. - External Labour monitoring. - Waterbirth monitoring using optional waterproof transducers. - Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the measurement of uterine activity for women with a history of preterm birth. - Domiciliary Non Stress Testing applications. The FETAL ASSIST is a prescription device.
    Device Description
    The FETAL ASSIST is a modular product that provides a portable antepartum fetal monitor that produces fetal cardiotocographs (CTGs). CTG traces are displayed in real time on the Liquid Crystal Display (LCD) which is integral to the Host Unit and can be reviewed or downloaded to an external printer and/or central location. The Assist can be powered by a stand-alone rechargeable battery pack. Alternatively, the Assist can be powered from the AC-powered supply via a power adapter.
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    K Number
    K002548
    Device Name
    FETAL ASSIST
    Manufacturer
    HUNTLEIGH DIAGNOSTICS LTD.
    Date Cleared
    2001-03-06

    (201 days)

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

    HUNTLEIGH DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001677
    Device Name
    BABY DOPPLEX 4000 (BD4000)
    Manufacturer
    HUNTLEIGH DIAGNOSTICS LTD.
    Date Cleared
    2000-08-14

    (74 days)

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

    HUNTLEIGH DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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