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

    Pulse Oximeter (Model C101A2, C101B1, C101A3)

    K Number: K221979 · Decision Oct 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    7
    Review Days
    103

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    Basic Information

    Device Name
    Pulse Oximeter (Model C101A2, C101B1, C101A3)
    K Number
    K221979
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Imdk Medical Technology Co., Ltd.
    Date Received
    July 5, 2022
    Decision Date
    October 16, 2022
    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 Shenzhen Imdk Medical Technology Co., Ltd.

    K Number Device Name
    K252655 Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
    K253133 Wrist Blood Pressure Monitor (BPM-W1VL)
    K243118 Arm Blood Pressure Monitor (model: BPM-A7VL)
    K233040 EMS/TENS Massager Device
    K173123 Pulse Oximeter
    K180419 Ultrasonic Doppler (Model YM-2T8)