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

    Percent Oxygen Sensors

    K Number: K213933 · Decision Aug 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    120
    Applicant Total
    1
    Review Days
    246

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    Basic Information

    Device Name
    Percent Oxygen Sensors
    K Number
    K213933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Careox, LLC
    Date Received
    December 16, 2021
    Decision Date
    August 19, 2022
    Product Code
    CCL
    Advisory Committee
    Anesthesiology
    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
    CCL Analyzer, Gas, Oxygen, Gaseous-Phase

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