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

    MODEL 3500 MR-COMPATIBLE PULSE OXIMETER

    K Number: K924285 · Decision May 11, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    259

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    Basic Information

    Device Name
    MODEL 3500 MR-COMPATIBLE PULSE OXIMETER
    K Number
    K924285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Magnetic Resonance Equipment Corp.
    Date Received
    August 25, 1992
    Decision Date
    May 11, 1993
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Magnetic Resonance Equipment Corp.

    K Number Device Name
    K003982 TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
    K983250 INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
    K954120 MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR
    K924282 MODEL 320 MR-COMPATIBLE PULSE OXIMETER