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

    OMNI II PATIENT MONITOR

    K Number: K103737 · Decision Jun 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    6
    Review Days
    162

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    Basic Information

    Device Name
    OMNI II PATIENT MONITOR
    K Number
    K103737
    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
    December 22, 2010
    Decision Date
    June 2, 2011
    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

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