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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    PATIENT MONITOR, MODEL PM50

    K Number: K101127 · Decision Jun 11, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    12
    Review Days
    50

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    Basic Information

    Device Name
    PATIENT MONITOR, MODEL PM50
    K Number
    K101127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contec Medical System Co., Ltd.
    Date Received
    April 22, 2010
    Decision Date
    June 11, 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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