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510(k) Data Aggregation

    K Number
    K020466
    Device Name
    HEC 1000
    Manufacturer
    METRO MEDICAL EQUIPMENT, INC.
    Date Cleared
    2002-05-08

    (85 days)

    Product Code
    KPJ
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRO MEDICAL EQUIPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Burns; Post Surgical Infections; Venous Stasis Ulcers; Diabetic Ulcers; Frostbite; Amputations / Infected Stumps; Skin Grafts
    Device Description
    Topical Oxygen Oxygen chambers / Topical Oxygen Chambers for Extremities. The chamber provides intermittent pressure up to 50 mmHg, cycling / ramping from 0 mmHg to 50 mmHg of pressure over a 15 to 20 second cycle, then venting back to 0mmHg of pressure within 5 seconds.
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