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

    FreeStyle Comfort (AS200 / FreeStyle Comfort)

    K Number: K250671 · Decision Jul 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    286
    Applicant Total
    7
    Review Days
    128

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    Basic Information

    Device Name
    FreeStyle Comfort (AS200 / FreeStyle Comfort)
    K Number
    K250671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5440
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caire, Inc.
    Date Received
    March 5, 2025
    Decision Date
    July 11, 2025
    Product Code
    CAW
    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
    CAW Generator, Oxygen, Portable

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