BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

    K Number: K240569 · Decision Nov 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
    K Number
    K240569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fink Engineering Pty, Ltd.
    Date Received
    February 29, 2024
    Decision Date
    November 21, 2024
    Product Code
    CBF
    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
    CBF Chamber, Hyperbaric

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    Other Clearances by Fink Engineering Pty, Ltd.

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