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

    JEDMED/POLACK KERATOSCOPE HS/SL

    K Number: K882618 · Decision Jul 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    JEDMED/POLACK KERATOSCOPE HS/SL
    K Number
    K882618
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Gamut Ent.
    Date Received
    June 24, 1988
    Decision Date
    July 13, 1988
    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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