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510(k) Data Aggregation

    K Number
    K071069
    Device Name
    MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
    Date Cleared
    2007-06-12

    (57 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS SLEEP SYSTEMS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VIASYS Sleep Systems Mini CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. The VIASYS Sleep Systems Mini CPAP device provides continuous positive airway pressure. The Humidifier accessory provides humidification of the air delivered to the patient.
    Device Description
    The Mini CPAP and Humidifier Accessory provide a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. The Mini CPAP device can be operated from mains supply or an optional battery. The Mini CPAP is comprised of a motorized blower assembly that provides positive air pressure. The blower speed is directly related to air pressure, and is controlled by software. The Mini CPAP and Humidifier Accessory consist of the following main components: CPAP blower, Humidifier, Power Supply, Therapy Tubing, Optional Battery and Charger. The Humidifier accessory is designed for operation only with the Mini CPAP device and utilizes a temperature controlled heated water tray and a manifold to provide humidified air to the patient. The humidification level is user adjustable. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements. The patient interface (CPAP mask) is a commercially available accessory provided separately.
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