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510(k) Data Aggregation
K Number
K971129Device Name
OXYPURE PORTABLE OXYGEN GENERATOR
Manufacturer
Date Cleared
1997-06-24
(89 days)
Product Code
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
ARBOR RESEARCH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Oxygen generated by a portable oxygen generator is supplemental and should not be considered life-supporting. Supplemental oxygen is non-addictive but should only be used at the specific liter flow and number of hours prescribed by your physician.
This device is intended for home use, in patients requiring supplemental oxygen for the palliative or therapeutic treatment of a variety of respiratory diseases, including emphysema, chronic obstructive pulmonary disease, cardiopulmonary insufficiency and bronchiectasis.
Federal law restricts this device to sale by or on the order of a licensed physician, and is to be prescribed only after appropriate clinical evaluation or oximetry screening tests have been performed on the patient by the prescribing physician.
This unit is not to be used for or with any life-supporting applications. Geriatic, pediatric, or any other patient unable to communicate discomfort while using this machine may require additional monitoring. In the event of an alarm or if you are experiencing any signs of patient discomfort, consult your physician immediately.
Device Description
OxyPure Portable Oxygen Generator
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