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

    STOCKERT HEATER-COOLER SYSTEM 3T

    K Number: K052601 · Decision Jun 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    29
    Applicant Total
    20
    Review Days
    258

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    Basic Information

    Device Name
    STOCKERT HEATER-COOLER SYSTEM 3T
    K Number
    K052601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Deutschland GmbH
    Date Received
    September 21, 2005
    Decision Date
    June 6, 2006
    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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