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

    ETG-4000 OPTICAL TOPOGRAPHY SYSTEM

    K Number: K042501 · Decision Oct 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    11
    Review Days
    28

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    Basic Information

    Device Name
    ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
    K Number
    K042501
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Corp.
    Date Received
    September 14, 2004
    Decision Date
    October 12, 2004
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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