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510(k) Data Aggregation
K Number
K102750Device Name
O2-IN-A-BOX, O2-IN-A-BOX
Manufacturer
Date Cleared
2011-02-11
(141 days)
Product Code
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
GETO2, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Emergency Use - OTC: Intended to produce oxygen for emergency use. There is a minimum 6 LPM flow rate for at least 15 minutes established a minimum total oxygen capacity of 90 liters. Environment of use - locations where emergency oxygen maybe needed.
Rx use: A portable oxygen generator intended to produce oxygen to provide supplemental oxygen as prescribed by a physician. Environment of use – Home, institutional, travel / mobile environments.
Device Description
A portable oxygen generator that utilizes a chemical reaction to generate oxygen. It is available in two versions: Emergency Use - OTC and Rx use. The Emergency Use version provides a minimum flow rate of 6 LPM for at least 15 minutes with a total oxygen capacity of 90 liters. The Rx use version provides variable flow rates (0.5 LPM for 60 minutes/30 liters capacity and 3 LPM for 30 minutes/90 liters capacity) as prescribed by a physician. Both versions are single use and disposable and use a standard oxygen mask or nasal cannula for patient interface.
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