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

    VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER

    K Number: K022028 · Decision Dec 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    179

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
    K Number
    K022028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular One, Inc.
    Date Received
    June 21, 2002
    Decision Date
    December 17, 2002
    Product Code
    KPJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPJ Chamber, Oxygen, Topical, Extremity

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KPJ), ordered by most recent decision date.

    Wound Treatment System (VHT-200)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VHT-200 Wound Treatment System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EPIFLO-28

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EPIFLO(R)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TANSCU O2

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all