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510(k) Data Aggregation

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

    (468 days)

    Product Code
    CBF
    Regulation Number
    868.5470
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the ATA HCM Monoplace Hyperbaric System. It formally approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.

    The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is an administrative letter confirming that the device can be legally marketed.

    Therefore, I cannot fulfill your request for information on acceptance criteria and studies from the provided text. The document is solely a regulatory approval, not a technical report detailing performance metrics or testing results.

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