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

    MASCOT CW DOPPLER SYSTEM

    K Number: K871212 · Decision Aug 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    19
    Review Days
    141

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    Basic Information

    Device Name
    MASCOT CW DOPPLER SYSTEM
    K Number
    K871212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Imex Medical Systems, Inc.
    Date Received
    March 26, 1987
    Decision Date
    August 14, 1987
    Product Code
    JOP
    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
    JOP Transducer, Ultrasonic

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