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

    OMNI EXPRESS

    K Number: K103268 · Decision Nov 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    OMNI EXPRESS
    K Number
    K103268
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infinium Medical
    Date Received
    November 4, 2010
    Decision Date
    November 23, 2010
    Product Code
    MWI
    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
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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    Other Clearances by Infinium Medical

    K Number Device Name
    K142244 CLEO PATIENT MONITOR
    K132229 OMNI PATENT MONITORS
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    K101052 OMNI III PATIENT MONITOR