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

    Vital Signs Monitor

    K Number: K211754 · Decision Nov 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    14
    Review Days
    161

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    Basic Information

    Device Name
    Vital Signs Monitor
    K Number
    K211754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Choice Electronic Technology Co., Ltd.
    Date Received
    June 7, 2021
    Decision Date
    November 15, 2021
    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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