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510(k) Data Aggregation

    K Number
    K984081
    Device Name
    EMOX
    Manufacturer
    EMOX 911 CC
    Date Cleared
    1999-03-17

    (121 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMOX 911 CC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.
    Device Description
    emOx Portable Oxygen Generator
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    K Number
    K984082
    Device Name
    BURN-AID HYDROGEL, BURN-AID BURN DRESSING, BURN-AID BURN BLANKET
    Manufacturer
    EMOX 911 CC
    Date Cleared
    1999-01-28

    (73 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMOX 911 CC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BURN-AID Hydrogel, Burn Dressing and Burn Blanket are indicated for single use as a pre-medical first aid for first and second degree burns and scalds to cool, soothe and moisturize the burn area.
    Device Description
    Not Found
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