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510(k) Data Aggregation

    K Number
    K040145
    Device Name
    ATA HCM MONOPLACE HYPERBARIC SYSTEM
    Date Cleared
    2005-05-04

    (468 days)

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

    ATA HYPERBARIC CHAMBER MANUFACTURING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The conditions listed as appropriate for the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: - Air or Gas Embolism . Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning - Clostridial Myositis and Myonecrosis (Gas Gangrene) . - Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias ◀ - Decompression Sickness ◆ - Enhancement of Healing in Selected Problem Wounds . - Exceptional Blood Loss (Anemia) . - . Intracranial Abscess - Necrotizing Soft Tissue Infections . - Osteomyelitis (Refractory) . - Delayed Radiation Injury (Soft Tissue and Bony Necrosis) ◆ - Skin Grafts and Flaps (Compromised) . - Thermal Burns .
    Device Description
    Monoplace Hyperbaric Chamber
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