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510(k) Data Aggregation

    K Number
    K042082
    Device Name
    AIRSTRIP OB
    Manufacturer
    MP4 SOLUTIONS, LP
    Date Cleared
    2005-01-21

    (171 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter for the AirStrip OB® device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

    Therefore, I cannot provide the requested information from the provided text.

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