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510(k) Data Aggregation

    K Number
    K130598
    Device Name
    INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
    Manufacturer
    INSPIRX, INC.
    Date Cleared
    2013-06-05

    (90 days)

    Product Code
    NVP
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSPIRX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InspiraChamber® Anti-Static Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs). Environment of use - Home, hospitals and clinics where patients may require the use of a holding chamber with pMDIs. The intended patient population is 3 years and older who have been prescribed pMDI medications.
    Device Description
    The InspiraChamber® is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber. The InspiraChamber® is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances: - · Corticosteroids (anti-inflammatory medications) - · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications) - · Non-steroidal chromones (DNCG) It is a single patient, multi-use, non-sterile device.
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