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510(k) Data Aggregation
K Number
K130598Device Name
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
Manufacturer
INSPIRX, INC.
Date Cleared
2013-06-05
(90 days)
Product Code
NVP
Regulation Number
868.5630Why 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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