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K Number
K020324
Device Name
LIFESTYLE OXYGEN CONCENTRATOR
Manufacturer
AIRSEP CORP.
Date Cleared
2002-03-13

(41 days)

Product Code
CAW
Regulation Number
868.5440
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The portable AirSep LifeStyle Oxygen Concentrator is intended to provide supplemental, high-purity oxygen in a home, institutional, or travel environment.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria and a study that proves a device meets those criteria. The text is a letter from the FDA to Airsep Corp. regarding the 510(k) premarket notification for the LifeStyle Oxygen Concentrator. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It does not include details about device performance, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).