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510(k) Data Aggregation

    K Number
    K082899
    Device Name
    DYNAMIPEAK PEAK FLOW METER
    Date Cleared
    2009-03-10

    (161 days)

    Product Code
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYNAMITECH MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DynamiPeak™ Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.
    Device Description
    The DynamiPeak™ Peak Flow Meter is a simple mechanical device that responds to and indicates the peak expiratory flow rate (PEFR) generated by the user during a forced exhalation maneuver. The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences, and internal piston extends a spring as it reacts to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic, thereby providing greater resolution of the scale at lower PEFR readings.
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