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510(k) Data Aggregation

    K Number
    K042945
    Device Name
    AURA CPAP SYSTEM
    Manufacturer
    AEIOMED INC.
    Date Cleared
    2005-03-09

    (135 days)

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

    AEIOMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.
    Device Description
    The aura CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. During obstructive sleep apnea, the airway collapses. When interfaced with a CPAP Mask or CPAP Patient Interface the aura CPAP System provides a constant pressure of 4 to 20 cmH2O above the ambient atmospheric pressure to patient's nasal airway. This constant pressure supports retaining an open airway during sleep. The aura CPAP System has four significant components: - 1) CPAP Blower, - 2) Optional Humidifier, - 3) Optional Battery Pack, and - 4) Patient Interface.
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    K Number
    K042130
    Device Name
    AURA CPAP PATIENT INTERFACE
    Manufacturer
    AEIOMED INC.
    Date Cleared
    2004-09-08

    (33 days)

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

    AEIOMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
    Device Description
    The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP. The Aura™ CPAP Patient Interface has three significant components: 1) Headgear Assembly, 2) Nasal Seal Assembly, and 3) Tubing and Adjustment Assembly. The Headgear Assembly holds the device Tubing and Adjustment Assembly, and the Nasal Seal Assembly in place on the user's head. The Headgear Assembly is adjustable by the user. The Nasal Seal Assembly is made from a silicone material which connects to the Tubing and Adjustment Assembly. The Nasal Seal Assembly provides the airflow pathway to the user's nasal openings. The Tubing and Adjustment Assembly connects to the CPAP System. The Tubing and Adjustment Assembly passes the constant air pressure of the CPAP System to the Nasal Seal Assembly. The Tubing and Adjustment Assembly allows the positioning of the Nasal Seal Assembly for the comfort of the user. The Tubing and Adjustment Assembly allows for the positions of the Nasal Seal Assembly in both dimensions: away from the face and in the vertical direction.
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