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

    INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER

    K Number: K033807 · Decision Mar 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    48
    Review Days
    92

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    Basic Information

    Device Name
    INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER
    K Number
    K033807
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2060
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical Systems, Inc.
    Date Received
    December 8, 2003
    Decision Date
    March 9, 2004
    Product Code
    DRQ
    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
    DRQ Amplifier And Signal Conditioner, Transducer Signal

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