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

    DX SERIES FINGER SENSOR

    K Number: K100020 · Decision Mar 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    DX SERIES FINGER SENSOR
    K Number
    K100020
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dixtal Medical, Inc.
    Date Received
    January 5, 2010
    Decision Date
    March 8, 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 Dixtal Medical, Inc.

    K Number Device Name
    K103285 DIXTAL DZ-4100 SERIES PULSE OXIMETER