BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

    K Number: K233963 · Decision Feb 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    8
    Review Days
    438

    Basic Information

    Device Name
    Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
    K Number
    K233963
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Taiwan Aulisa Medical Devices Technologies, Inc.
    Date Received
    December 15, 2023
    Decision Date
    February 25, 2025
    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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