BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Quantum Workstation 12 Elite

    K Number: K202557 · Decision Oct 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    46
    Applicant Total
    9
    Review Days
    29

    Basic Information

    Device Name
    Quantum Workstation 12 Elite
    K Number
    K202557
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Medical Ltd
    Date Received
    September 3, 2020
    Decision Date
    October 2, 2020
    Product Code
    DRY
    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
    DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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