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510(k) Data Aggregation

    K Number
    K023245
    Device Name
    BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2002-10-21

    (21 days)

    Product Code
    NJJ
    Regulation Number
    886.1930
    Why did this record match?
    Product Code :

    NJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, Pulsatility Index Equivalent (PEQ).
    Device Description
    The Paradigm Medical Industries, Inc. Blood Flow Analyzer (BFA) is an electronic pneumatic tonometer capable of measuring and recording the intraocular pressure. The pressure measurements are made at a rate of 200 times per second over a period of 5-15 seconds. Contact with the eye is by means of a sterilized single-use per patient probe having an integral membrane that isolates the cornea from the internal pneumatic operation of the BFA. The pulsatile ocular blood flow is derived from the intraocular pressure measurements acquired with the pneumatic tonometer using mathematical equations that link intraocular pressure to ocular volume change and volume flow.
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