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510(k) Data Aggregation

    K Number
    K971644
    Device Name
    CEBE
    Manufacturer
    SUUNTO USA
    Date Cleared
    1997-06-24

    (50 days)

    Product Code
    HQY
    Regulation Number
    886.5850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Eye Protection against ultra violet radiation.

    Device Description

    CEBE SUNGLASSES

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for "CEBE SUNGLASSES" and an "Indications For Use" form. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving a device meets acceptance criteria.

    The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on substantial equivalence to a predicate device, not on a new study proving the device meets specific performance acceptance criteria.

    Therefore, I cannot provide the requested information from the given text.

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