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

    MODEL 200

    K Number: K830468 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    MODEL 200
    K Number
    K830468
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4445
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Western Laboratories Corp.
    Date Received
    February 15, 1983
    Decision Date
    April 12, 1983
    Product Code
    FTZ
    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
    FTZ Locator, Magnetic

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