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

    Quantum Heater-Cooler

    K Number: K212657 · Decision May 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    15
    Review Days
    256

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    Basic Information

    Device Name
    Quantum Heater-Cooler
    K Number
    K212657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Medical , Ltd.
    Date Received
    August 23, 2021
    Decision Date
    May 6, 2022
    Product Code
    DWC
    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
    DWC Controller, Temperature, Cardiopulmonary Bypass

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