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

    PATIENT MONITOR

    K Number: K123711 · Decision Oct 1, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    11
    Review Days
    301

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    Basic Information

    Device Name
    PATIENT MONITOR
    K Number
    K123711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Creative Industry Co., Ltd.
    Date Received
    December 4, 2012
    Decision Date
    October 1, 2013
    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 Shenzhen Creative Industry Co., Ltd.

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    K093016 VITAL SIGNS MONITOR
    K082055 MODEL PC-860 FETAL DOPPLER
    K073152 PC-180 / PRINCE 180 EASY ECG MONITOR
    K063641 PC-60, NON-INVASIVEPULSE OXIMETER
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