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

    BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

    K Number: K911351 · Decision Aug 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    28
    Review Days
    148

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    Basic Information

    Device Name
    BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP
    K Number
    K911351
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biochem International, Inc.
    Date Received
    March 27, 1991
    Decision Date
    August 22, 1991
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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