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

    SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G

    K Number: K023745 · Decision Jan 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
    K Number
    K023745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sechrist Industries, Inc.
    Date Received
    November 7, 2002
    Decision Date
    January 17, 2003
    Product Code
    DTX
    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
    DTX Gas Control Unit, Cardiopulmonary Bypass

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