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510(k) Data Aggregation
K Number
K042944Device Name
HOME-AWAY SYSTEM, MODEL 1041
Manufacturer
IN-X CORPORATION
Date Cleared
2005-04-15
(172 days)
Product Code
CAW, BYJ
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
IN-X CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.
Device Description
The Home-Away System, Model 1041 is an accessory to an oxygen concentrator and liquid oxygen (LOX) stroller. It liquefies oxygen that is received from an oxygen nquia entygen (t, and delivers it to a LOX stroller for patient use. While performing these functions, it is also capable of delivering up to 3 L/min of gaseous oxygen directly to the patient. In these respects, the Home-Away System, Model 1041 is the same as its to the payment Home-Away System. The Home-Away System, Model 1041 incorporates prounders from the cleared device that enhance its usability, manufacturability, consistent performance, durability, reliability, and safety.
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