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

    LENSOMETER MODEL 11

    K Number: K781440 · Decision Sep 7, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    65
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    20

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    Basic Information

    Device Name
    LENSOMETER MODEL 11
    K Number
    K781440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1425
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Rodenstock Instrument Corp.
    Date Received
    August 18, 1978
    Decision Date
    September 7, 1978
    Product Code
    HLM
    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
    HLM Instrument, Measuring, Lens, Ac-Powered

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