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510(k) Data Aggregation

    K Number
    K042082
    Device Name
    AIRSTRIP OB
    Manufacturer
    Date Cleared
    2005-01-21

    (171 days)

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

    MP4 SOLUTIONS, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AirStrip OB® is intended to be used by Obstetricians for the following purposes: - To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction by viewing the real time waveforms remotely using a mobile device such as a PDA or Smart Phone - To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time. - To review the current Labor and Delivery patient census list. - Provide a request for remote consultation regarding a fetal heart tracing. - To remotely review other standard or critical real-time numeric data from Labor and Delivery.
    Device Description
    Not Found
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