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510(k) Data Aggregation

    K Number
    K981821
    Manufacturer
    Date Cleared
    1998-07-29

    (68 days)

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

    VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR

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

    The VES 3001/w use is indicated in the following situations:

    • Whenever there is a need for head lamp illumination of the fiber-optic type .
    • When ever there is a need for a fiber-optic illuminator for an endoscope .
    • . When ever there is a need to use video either as a visual aid for as a method of recording or both.
    • When ever there is a requirement for any or all of the above at the same . time.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "VES 3001/2 Dual Output Video Illuminator."

    This document does not contain the kind of information requested in your prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, ground truth methods, or details about training sets. The letter is a regulatory approval document confirming substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information from this text.

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