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

    ABL80 FLEX CO-OX with AQURE connectivity

    K Number: K151856 · Decision Aug 6, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    ABL80 FLEX CO-OX with AQURE connectivity
    K Number
    K151856
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sendx Medical, Inc.
    Date Received
    July 8, 2015
    Decision Date
    August 6, 2015
    Product Code
    CHL
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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    Other Clearances by Sendx Medical, Inc.

    K Number Device Name
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