BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PANORAMIC LOUPES - VARIOUS

    K Number: K841293 · Decision May 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    41

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    Basic Information

    Device Name
    PANORAMIC LOUPES - VARIOUS
    K Number
    K841293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1640
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Keller Instruments, Inc.
    Date Received
    March 29, 1984
    Decision Date
    May 9, 1984
    Product Code
    HLT
    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
    HLT Preamplifier, Ac-Powered, Ophthalmic

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