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510(k) Data Aggregation

    K Number
    K201167
    Device Name
    AireHealth NebulizerTM
    Manufacturer
    AireHealth Inc.
    Date Cleared
    2020-12-03

    (216 days)

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

    AireHealth Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AireHealth™ Nebulizer electronic vibrating mesh nebulize liquid medications for inhalation by a patient. The AireHealth™ Nebulizer may be used in adults or children 5 years of age and older. The AireHealth™ Nebulizer is a portable Nebulizer for use in and out of the home environment. The AireHealth™ Nebulizer is not intended as a life sustaining or life-supporting device. The AireHealth™ Nebulizer is not intended for use with Pentamidine.
    Device Description
    The AireHealth" Nebulizer, model AH-04, is a portable electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient in and out of the home environment. The Nebulizer may be used in adults or children 5 years of age and older. The AireHealth™Nebulizer vibrating mesh nebulizer incorporates a piezoelectric transducer that vibrates at a nominal frequency (115kHz) when electrical current is applied. The vibration of the transducer is transmitted to a metal alloy mesh vapor disk that contains approximately 5,000 holes that are in contact with the liquid to be nebulized. An electrical charge applied to the piezoelectric transducer, in turn, leads to vibration (inward and outward movement of the mesh vapor disk), passing the liquid through the holes to form an aerosol. The AireHealth™ Nebulizer is battery operated. The handset in the AireHealth 100 Nebulizer has a use life of 3 years. Liquid medication is placed in the medicine cup which should be cleaned after every use. The medicine cup should be replaced every 90 days. The Nebulizer is capable of providing use and status information to a companion application wirelessly via Bluetooth connection. The companion application is an optional accessory for displaying purposes only and will not allow operation or control of the nebulizer. The companion application is not a medical device.
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