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

    BIOX III

    K Number: K820110 · Decision Feb 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    BIOX III
    K Number
    K820110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Biox Technology, Inc.
    Date Received
    January 15, 1982
    Decision Date
    February 12, 1982
    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 Biox Technology, Inc.

    K Number Device Name
    K833826 BTI BIOX III OXIMETER CRITICAL CAREUNI