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510(k) Data Aggregation

    K Number
    K030713
    Device Name
    BAY AREA HYPERSCIENCES
    Manufacturer
    BAY AREA HYPERSCIENCES, LLC
    Date Cleared
    2003-12-19

    (288 days)

    Product Code
    CBF
    Regulation Number
    868.5470
    Type
    Abbreviated
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
      1. Air or gas embolism
      1. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
      1. Clostridial myositis and myonecrosis
      1. Crush injury, compartment syndrome or other acute traumatic ischemias
      1. Decompression sickness
      1. Enhanced healing of selected problem wounds
      1. Exceptional blood loss anemia
      1. Necrotizing soft tissue infections
      1. Osteomyelitis (refractory)
      1. Delaved radiation injury (soft tissue and bone necrosis)
      1. Skin grafts and flaps (compromised)
      1. Thermal burns
      1. Intracranial abscesses
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a hyperbaric chamber. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than a direct performance study against specific acceptance criteria.

    Therefore, I cannot extract the requested information as it is not present in the given text.

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