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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    THERMODILUTION CATHETER

    K Number: K101669 · Decision Jul 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    THERMODILUTION CATHETER
    K Number
    K101669
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosensors Intl. Pte. , Ltd.
    Date Received
    June 14, 2010
    Decision Date
    July 1, 2010
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Biosensors Intl. Pte. , Ltd.

    K Number Device Name
    K083384 THERMODILUTION CATHETER