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K Number
K202389
Device Name
Oxygen Concentrator
Manufacturer
Foshan MIC Medical Technology Co., LTD
Date Cleared
2022-04-08

(595 days)

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

The OXYGEN CONCENTRATOR is intended to provide supplemental oxygen in a home, institutional, or travel environment.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for an Oxygen Concentrator. It does not contain any information about acceptance criteria, device performance, study details, human reader studies, or ground truth establishment relevant to an AI/ML device. Therefore, I cannot fulfill your request based on the given input.

§ 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).