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

    OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN

    K Number: K062999 · Decision Nov 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    18
    Applicant Total
    45
    Review Days
    32

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    Basic Information

    Device Name
    OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
    K Number
    K062999
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hospira, Inc.
    Date Received
    October 2, 2006
    Decision Date
    November 3, 2006
    Product Code
    DQE
    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
    DQE Catheter, Oximeter, Fiber-Optic

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