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

    MARCO PROJECTION PERIMETER

    K Number: K930448 · Decision Jun 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    5
    Applicant Total
    15
    Review Days
    146

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    Basic Information

    Device Name
    MARCO PROJECTION PERIMETER
    K Number
    K930448
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Marco Ophthalmic, Inc.
    Date Received
    January 26, 1993
    Decision Date
    June 21, 1993
    Product Code
    HOO
    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
    HOO Perimeter, Ac-Powered

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    K930442 MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS
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