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

    FIELD TREND

    K Number: K954037 · Decision Nov 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    67
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    FIELD TREND
    K Number
    K954037
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Synemed, Inc.
    Date Received
    August 28, 1995
    Decision Date
    November 17, 1995
    Product Code
    HPT
    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
    HPT Perimeter, Automatic, Ac-Powered

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