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    K Number
    K970887
    Device Name
    BLOOD FLOW ANALYZER
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1997-06-17

    (98 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K873422
    Why did this record match?
    Reference Devices :

    K873422

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

    Device Description

    A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.

    AI/ML Overview

    The Blood Flow Analyzer, manufactured by Paradigm Medical Industries, Inc., is a tonometer and accessories intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). This device is intended for use in the diagnosis of glaucoma.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Degree of Accuracy (
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