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510(k) Data Aggregation

    K Number
    K042889
    Device Name
    DYNAMOMETER - MODEL FCE AND MODEL MSC
    Manufacturer
    AMETEK
    Date Cleared
    2004-11-16

    (28 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMETEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Chatillon FCE and MSC series dynamometers is for performing manual muscle testing to measure muscle strength. The target population for this product is individuals recovering from physical injury or for sports medicine applications.
    Device Description
    The Chatillon FCE and MSC series dynamometers are diagnostic devices used for evaluating muscle strength. These instruments are powered by a rechargeable battery (4.8 VDC) which supplied a regulated 2.5 VDC excitation voltage to a strain gauge load cell. The analog output from the load cell (2 mV/V) is then converted to a digital signal that is directly proportional to the applied force. This digital signal is then sent to a microprocessor, which converts the signal to a force value that is stored in memory and/or displayed on the dynamometer graphical display. This design has been used for many years in industrial force measuring instruments and has been also used for physical therapy, occupational medicine and sports medicine. These medical dynamometers are a repackaged version of the industrial force measurement instruments and are designed with special medical attachments that are appropriate for performing manual muscle testing and ergonomic analysis.
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    K Number
    K943824
    Device Name
    GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
    Manufacturer
    AMETEK, INC.
    Date Cleared
    1996-11-01

    (914 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMETEK, INC

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