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510(k) Data Aggregation
K Number
K203086Device Name
X-PLO2R
Manufacturer
Belluscura LLC
Date Cleared
2021-03-02
(140 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
Belluscura LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-PLO2R is a transportable, software-monitored device designed to be used by patients as a portable oxygen delivery system requiring high concentrations of oxygen on a supplemental basis. It is small, portable of continuous use in home, institutional, and travel/ mobile environments.
Device Description
The X-PLO2R is a transportable, software-monitored device designed to be used by patients as a portable oxygen delivery system requiring high concentrations of oxygen on a supplemental basis. It is small, portable of continuous use in home, institutional, and travel/ mobile environments.
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