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

    PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500

    K Number: K113183 · Decision Feb 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    2
    Review Days
    104

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    Basic Information

    Device Name
    PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
    K Number
    K113183
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai 3f Electronics Co, Ltd.
    Date Received
    October 28, 2011
    Decision Date
    February 9, 2012
    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 Shanghai 3f Electronics Co, Ltd.

    K Number Device Name
    K100394 MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A