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FDA 510(k)

Invacare Platinum 5NXG Oxygen Concentrator

K-Number: K203210 · 2021-04-12

ApplicantInvacare Corporation
Decision Date2021-04-12
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Invacare Platinum 5NXG Oxygen Concentrator is a medical device manufactured by Invacare Corporation. It received FDA 510(k) clearance on 2021-04-12 under approval number K203210. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invacare Platinum 5NXG Oxygen Concentrator?

Invacare Platinum 5NXG Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2021-04-12. It is manufactured by Invacare Corporation. The 510(k) number is K203210.

When was Invacare Platinum 5NXG Oxygen Concentrator approved by the FDA?

Invacare Platinum 5NXG Oxygen Concentrator received FDA 510(k) clearance on 2021-04-12, under approval number K203210.

What company makes Invacare Platinum 5NXG Oxygen Concentrator?

Invacare Platinum 5NXG Oxygen Concentrator is manufactured by Invacare Corporation.

What is the FDA product code for Invacare Platinum 5NXG Oxygen Concentrator?

The FDA product code for Invacare Platinum 5NXG Oxygen Concentrator is CAW.

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Related Devices (Code: CAW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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