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510(k) Data Aggregation

    K Number
    K972225
    Date Cleared
    1998-03-18

    (278 days)

    Product Code
    Regulation Number
    878.4580
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UFR FIBEROPTIC CABLE

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

    The UFR fiberoptic cable is Intended to transmit light for illumination purposes from light source to various instruments such as headlights, microscopes, endoscopes, etc. It is manufactured to the buyers' specifications and is intended for use with the buyers' existing equipment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for a fiberoptic light cable. It outlines the regulatory approval process and includes the device's indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

    Therefore, I cannot provide the requested table and information based on the input text. The document focuses on regulatory approval based on substantial equivalence to existing devices, not on detailed performance study results.

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