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

    MARQUETTE SV O2 MODULE

    K Number: K915073 · Decision Dec 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    18
    Applicant Total
    82
    Review Days
    417

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    Basic Information

    Device Name
    MARQUETTE SV O2 MODULE
    K Number
    K915073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquette Electronics, Inc.
    Date Received
    November 8, 1991
    Decision Date
    December 29, 1992
    Product Code
    DQE
    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
    DQE Catheter, Oximeter, Fiber-Optic

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