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

    TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT

    K Number: K061573 · Decision Sep 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    45
    Review Days
    104

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    Basic Information

    Device Name
    TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
    K Number
    K061573
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospira, Inc.
    Date Received
    June 7, 2006
    Decision Date
    September 19, 2006
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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