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510(k) Data Aggregation

    K Number
    K972908
    Device Name
    SANDS SERIES III HYPERBARIC CHAMBER
    Manufacturer
    Date Cleared
    1998-07-22

    (350 days)

    Product Code
    Regulation Number
    868.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANDS HYPERBARICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    APPROVED USES AND THRESHOLD LEVELS FOR THE NUMBER OF HYPERBARIC TREATMENTS (As published by the Undersea and Hyperbaric Medical Society's (UHMS) Oxygen Committee 1995) 1. Air or Gas Embolism 2. Carbon Monoxide Poisoning and Smoke Inhalation 3. Clostridial Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias 5. Decompression Sickness 6. Enhanced Healing in Selected Problem Wounds 7. Exceptional Blood Loss (anemia) 8. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 9. Osteomyelitis (refractory) 10. Radiation Tissue Damage (Osteoradionecrosis) 11. Skin Grafts and Flaps (compromised) 12. Thermal Burns
    Device Description
    A hyperbaric oxygen treatment ("HBOT") chamber is a pressure vessel that is large enough to accommodate a person or persons. It is capable of being energized with a gas, either air, oxygen, or a mix of the two. Therapeutic pressures are rarely more than 100 PSIG. The chamber itself can be fabricated from steel, acrylic or any substance designed to cope with the designed working pressure of the chamber. A HBOT chamber normally has the following features *: - at least one doorway large enough to permit entry and exit, - a number of windows which permit observation of the occupants, - a pressurization and depressurization system which also serves to ventilate the interior of the chamber, - a way of providing 100% oxygen to the patient, either by way of breathing the compartment gas when the HBOT chamber is energized by oxygen or by a mask.
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