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

    REUSABLE SURGICAL KERATOSCOPE

    K Number: K864639 · Decision Dec 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    92
    Review Days
    33

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    Basic Information

    Device Name
    REUSABLE SURGICAL KERATOSCOPE
    K Number
    K864639
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Jedmed Instrument Co.
    Date Received
    November 26, 1986
    Decision Date
    December 29, 1986
    Product Code
    HLR
    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
    HLR Keratoscope, Battery-Powered

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