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

    CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM

    K Number: K855229 · Decision Mar 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM
    K Number
    K855229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vingmed, Inc.
    Date Received
    December 30, 1985
    Decision Date
    March 25, 1986
    Product Code
    DXK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXK Echocardiograph

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