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

    CARDIAC SECTOR PROBE 5.0 MHZ

    K Number: K850216 · Decision Apr 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    781
    Review Days
    78

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    Basic Information

    Device Name
    CARDIAC SECTOR PROBE 5.0 MHZ
    K Number
    K850216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    January 22, 1985
    Decision Date
    April 10, 1985
    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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