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510(k) Data Aggregation

    K Number
    K170853
    Device Name
    InnoSpire Go
    Date Cleared
    2017-11-02

    (225 days)

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

    Respironics Respiratory Drug Delivery (UK) Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication, and adults patients in the home environment or in a hospital/clinic setting.
    Device Description
    The InnoSpire Go nebulizer is a small, handheld, internally powered nebulizer which utilizes vibrating mesh technology to generate aerosol.
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    K Number
    K102454
    Device Name
    I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
    Date Cleared
    2011-10-25

    (424 days)

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

    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The I-neb AAD system with TIM is a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. The I-neb Insight AAD System is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. It is an accessory to an accessory for use with the I-neb AAD system. The I-neb AAD system with TIM is intended for patients 3 years and older who can coordinate breathing.
    Device Description
    The I-neb AAD System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. The I-neb Insight AAD System is an accessory for use with the I-neb AAD system and controls monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. The I-neb AAD system with TIM incorporates a modification of the predicate I-neb AAD system with (tidal breathing mode (TBM)), K042991. While the I-neb Insight incorporates updated software to accommodate the added TIM feature, it is a modification of the predicate I-neb Insight AAD System, K052941.
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