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

    MD300C1 FINGERTIP PULSE OXIMETER

    K Number: K093757 · Decision Mar 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    29
    Review Days
    86

    Basic Information

    Device Name
    MD300C1 FINGERTIP PULSE OXIMETER
    K Number
    K093757
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
    Date Received
    December 7, 2009
    Decision Date
    March 3, 2010
    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 TECHNOLOLGY CO., LTD.

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