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510(k) Data Aggregation

    K Number
    K160950
    Device Name
    MINISCAV
    Manufacturer
    Sedation Systems LLC
    Date Cleared
    2017-05-05

    (395 days)

    Product Code
    CBN, BTA
    Regulation Number
    868.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sedation Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases. This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
    Device Description
    The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment. The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.
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