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510(k) Data Aggregation

    K Number
    K100121
    Device Name
    MODEL 300157 CPAP SYSTEM
    Manufacturer
    AEIOMED, INC.
    Date Cleared
    2010-07-13

    (179 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 Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.
    Device Description
    The CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. When interfaced with a CPAP Mask or CPAP Patient Interface the CPAP System provides a constant pressure of 4 to 20 cmHzO above the ambient atmospheric pressure to patient's nasal airway. This constant pressure, when set to a therapeutic level as prescribed by a physician, supports retaining an open airway during sleep. The CPAP System has primary components: 1) CPAP main unit, 2) Removable headgear, 3) External power supply/optional mobile power adaptor, and 4) Patient Interface.
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    K Number
    K072993
    Device Name
    REUSABLE HEADREST WITH NASAL SEAL
    Manufacturer
    AEIOMED, INC.
    Date Cleared
    2008-02-08

    (108 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 Headrest® with Nasal Seal is a reusable 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 Headrest® with Nasal Seal 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 Headrest® with Nasal Seal is initially used under the direct supervision of a trained medical professional. The Headrest® with Nasal Seal function and applications are applied in a clinical or home setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy. The Headrest® with Nasal Seal has three significant components: 1) Headrest, 2) Nasal Seal, and 3) Tubing. The Headrest holds the device Tubing and the Nasal Seal in place on the user's head. The Headrest is adjustable by the user. The Nasal Seal is made from a silicone material which connects to the Headrest. The Nasal Seal provides the airflow pathway to the user's nasal openings. The Tubing connects to the CPAP System. The Tubing and Headrest pass the constant air pressure of the CPAP System to the Nasal Seal. The Headrest allows the positioning of the Nasal Seal for the comfort of the user. The Headrest and Nasal Seal are reusable components. The Tubing is single patient use.
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