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

    OMNI PATENT MONITORS

    K Number: K132229 · Decision Feb 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    6
    Review Days
    218

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    Basic Information

    Device Name
    OMNI PATENT MONITORS
    K Number
    K132229
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infinium Medical
    Date Received
    July 18, 2013
    Decision Date
    February 21, 2014
    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
    K112329 OMNI PATIENT MONITOR
    K103737 OMNI II PATIENT MONITOR
    K103268 OMNI EXPRESS
    K101052 OMNI III PATIENT MONITOR