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

    Pulse Oximeter (MD300M/MD300K2)

    K Number: K152563 · Decision Apr 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    14
    Review Days
    222

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    Basic Information

    Device Name
    Pulse Oximeter (MD300M/MD300K2)
    K Number
    K152563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Choice Electronic Technology Co., Ltd.
    Date Received
    September 9, 2015
    Decision Date
    April 18, 2016
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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    Other Clearances by Beijing Choice Electronic Technology Co., Ltd.

    K Number Device Name
    K232975 Pulse Oximeter (MD300C228)
    K230587 Wrist Pulse Oximeter
    K230172 Pulse Oximeter
    K220101 Pulse Oximeter
    K221992 Electronic Pulse Stimulator
    K211400 Pulse Oximeter
    K211752 Infrared Thermometer
    K211754 Vital Signs Monitor
    K181503 Fingertip Pulse Oximeter
    K172366 Wrist Pulse Oximeter
    Search all 14 clearances from Beijing Choice Electronic Technology Co., Ltd. →