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510(k) Data Aggregation

    K Number
    K971995
    Device Name
    MEDIVISION SINOSCOPE
    Manufacturer
    MEDIVISION SCOPE SERVICE CENTER, INC.
    Date Cleared
    1997-06-26

    (27 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDIVISION SINOSCOPE

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

    Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria, device performance, or any study details for the MediVision Sinoscope.

    The text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It states the intended use of the device: "Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity."

    However, it does not include any performance data, study designs, sample sizes, expert qualifications, or ground truth information. Therefore, I cannot generate the requested table and study description.

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