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

    Revitalair 430+

    K Number: K220290 · Decision May 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    1
    Review Days
    457

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    Basic Information

    Device Name
    Revitalair 430+
    K Number
    K220290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Us Hyperbaric Network
    Date Received
    February 1, 2022
    Decision Date
    May 4, 2023
    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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