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

    KAMPPETER ANOMALOSCOPE

    K Number: K930575 · Decision Feb 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    386

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    Basic Information

    Device Name
    KAMPPETER ANOMALOSCOPE
    K Number
    K930575
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1070
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bova Intl.
    Date Received
    February 4, 1993
    Decision Date
    February 25, 1994
    Product Code
    HIW
    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
    HIW Anomaloscope

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