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510(k) Data Aggregation

    K Number
    K081693
    Device Name
    NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
    Manufacturer
    INSTRUMENTATION INDUSTRIES, INC.
    Date Cleared
    2008-09-11

    (86 days)

    Product Code
    BXR
    Regulation Number
    868.1780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort. Federal law restricts these devices to sale by or on the order of a physician.
    Device Description
    The NS Series NIF Meters are intended to measure inspiratory airway pressures of up to 30, 60 or 120 cm H2O , dependent upon the specific model used.
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    K Number
    K032593
    Device Name
    MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
    Manufacturer
    MERCURY MEDICAL
    Date Cleared
    2004-02-03

    (165 days)

    Product Code
    BXR
    Regulation Number
    868.1780
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force.
    Device Description
    The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.
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