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    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)

    K Number: K252746 · Decision May 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    265

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    Basic Information

    Device Name
    Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
    K Number
    K252746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drägerwerk AG Co. Kgaa
    Date Received
    August 29, 2025
    Decision Date
    May 21, 2026
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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    Other Clearances by Drägerwerk AG Co. Kgaa

    K Number Device Name
    K230931 Atlan