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

    MODIFIED RADIUS - MODEL NUMBER MM 5000

    K Number: K871727 · Decision Sep 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    155

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    Basic Information

    Device Name
    MODIFIED RADIUS - MODEL NUMBER MM 5000
    K Number
    K871727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ultrasonix, Inc.
    Date Received
    April 28, 1987
    Decision Date
    September 30, 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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