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510(k) Data Aggregation

    K Number
    K023618
    Device Name
    SONICAID ONE
    Manufacturer
    OXFORD INSTRUMENTS MEDICAL LTD.
    Date Cleared
    2003-01-22

    (85 days)

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

    OXFORD INSTRUMENTS MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonicaid®One Fetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.
    Device Description
    Sonicaid® One Fetal Heart Detector
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