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510(k) Data Aggregation
K Number
K170853Device Name
InnoSpire Go
Manufacturer
Date Cleared
2017-11-02
(225 days)
Product Code
Regulation Number
868.5630Why 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
K102454Device Name
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
Manufacturer
Date Cleared
2011-10-25
(424 days)
Product Code
Regulation Number
868.5630Why 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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