BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

    K Number: K063434 · Decision Jan 22, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
    K Number
    K063434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiometer Basel AG
    Date Received
    November 13, 2006
    Decision Date
    January 22, 2007
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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