BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    FIBER HEAD LIGHT FH-300

    K Number: K951337 · Decision Jun 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    24
    Review Days
    76

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    Basic Information

    Device Name
    FIBER HEAD LIGHT FH-300
    K Number
    K951337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4335
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neitz Instruments Company, Ltd.
    Date Received
    March 24, 1995
    Decision Date
    June 8, 1995
    Product Code
    HPQ
    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
    HPQ Headlamp, Operating, Ac-Powered

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