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

    SPECTABLE FRAME MAGNIFYING BRILLETTE

    K Number: K844657 · Decision Dec 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    SPECTABLE FRAME MAGNIFYING BRILLETTE
    K Number
    K844657
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1810
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Pro Design Intl. AS
    Date Received
    November 29, 1984
    Decision Date
    December 11, 1984
    Product Code
    HOJ
    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
    HOJ Screen, Tangent, Target

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HOJ), ordered by most recent decision date.

    TANGENT SCREEN

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CHART PROJECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
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    Other Clearances by Pro Design Intl. AS

    K Number Device Name
    K844658 SPECTABLE FRAME - PRODESIGN SUN CLUB