BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DIGI SPORTLENS SYSTEM

    K Number: K921444 · Decision Jul 13, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    2
    Review Days
    110

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    Basic Information

    Device Name
    DIGI SPORTLENS SYSTEM
    K Number
    K921444
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fitness Quest, Inc.
    Date Received
    March 25, 1992
    Decision Date
    July 13, 1992
    Product Code
    HQY
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQY Sunglasses (Non-Prescription Including Photosensitive)

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