LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022214
    Device Name
    MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
    Manufacturer
    MECHIDYNE SYSTEMS, INC.
    Date Cleared
    2003-02-26

    (233 days)

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

    MECHIDYNE SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - 1 Air or Gas Embolism - 2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning - 3 Clostridal Myositis and Myonecrosis (Gas Gangrene) - Crush Injury, Compartment Syndrome, and other Acute 4 Traumatic Ischemias - 5 Decompression Sickness - Enhancement of Healing in Selected Problem Wounds - 7 Exceptional Blood Loss (Anemia) - 8 Intracranial Abscess - 9 Necrotizing Soft Tissue Infections - 10 Osteomyelitis (Refractory) - 11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis - 12 Skin Grafts & Flaps (Compromised) - 13 Thermal Burns These are the indicated uses by the Undersea & Hyperbaric Medical Society. The device is designed to be used for the indicated uses only.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1