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Airsep NewLife Dual Six Oxygen Concentrator (Modification)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960309

by Airsep Corp.

Identifiers

510(k) Number
K960309 FDA 510(k)
FDA Product Code
CAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5440 FDA 510(k)
Regulation Number
868.5440 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Airsep NewLife Dual Six Oxygen Concentrator (Modification) is a portable oxygen generator that releases oxygen for respiratory therapy by means of physical means such as a molecular sieve. It is designed to provide oxygen for patients requiring respiratory therapy in various settings.

This device is supplied by Airsep Corp. and has FDA 510K clearance with product code CAW. It is classified as a Class II medical device and is intended for use in anesthesiology. The device is portable and designed for oxygen generation, though specific details on sterility, single-use or reusable status, MRI safety, and storage are not provided in the data.

Frequently asked questions

What is the Airsep NewLife Dual Six Oxygen Concentrator used for?

The Airsep NewLife Dual Six Oxygen Concentrator is a portable oxygen generator designed to provide oxygen for patients requiring respiratory therapy in various settings, particularly in anesthesiology.

How is the Airsep NewLife Dual Six Oxygen Concentrator supplied?

The device is supplied by Airsep Corp. and has FDA 510K clearance with product code CAW. It is classified as a Class II medical device.

Is the Airsep NewLife Dual Six Oxygen Concentrator single-use or reusable?

The device data does not specify whether the Airsep NewLife Dual Six Oxygen Concentrator is single-use or reusable. Additional information would be needed to determine its intended use pattern.

What is the regulatory status of the Airsep NewLife Dual Six Oxygen Concentrator?

The device has FDA 510K clearance with product code CAW and is classified as a Class II medical device. It is intended for use in anesthesiology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Airsep NewLife Manuals | ManualsLib, AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) by AIRSEP ..., Airsep Newlife Dual Six Oxygen Concentrator (Modification), AIRSEP NEWLIFE ELITE PATIENT MANUAL Pdf Download, K960309 FDA 510(k) - AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTR...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Airsep Corp.

Sources (1)

  • FDA 510(k) K960309 24 fields · synced Sep 24, 2026