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

    PLACIDO DISC

    K Number: K854054 · Decision Dec 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    PLACIDO DISC
    K Number
    K854054
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Cutler Medical Instruments
    Date Received
    October 3, 1985
    Decision Date
    December 27, 1985
    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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