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510(k) Data Aggregation

    K Number
    K172365
    Device Name
    Panoramic Oxygen Mask (POM)
    Manufacturer
    Pom Medical, LLC
    Date Cleared
    2018-04-19

    (258 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pom Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Panoramic Oxygen Mask (POM) is a single patient, disposable device intended for delivering supplemental oxygen and monitoring expired gases from the patient, with ports to allow the clinician to insert scopes, probes, or tubes. It is for non-intubated, spontaneously breathing patients greater than 30 kg.
    Device Description
    The Panoramic Oxygen Mask (POM) is a multi-port mask that serves several functions: - A standard oxygen mask for when a patient requires supplemental oxygen - Sampling of exhaled gases for monitoring, typically end-tidal CO2 - Additional ports (membranes) to allow for most types of scopes, probes, and tubes to be inserted while still delivering supplemental O2 and sampling exhaled gases. The design of the POM's oral or nasal membranes allow access of a scope and are soft and pliable to help maintain the oxygen concentration to the patient while having scopes, etc. inserted through these oral or nasal membranes.
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