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FDA 510(k)

Invacare Platinum 5NXG Oxygen Concentrator

K-Number: K203210 · 2021-04-12

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

Device Summary

Invacare Platinum 5NXG Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2021-04-12 under 510(k) 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. The listed applicant is Invacare Corporation. The 510(k) number is K203210.

When did Invacare Platinum 5NXG Oxygen Concentrator receive FDA 510(k) clearance?

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

Who is the listed applicant for Invacare Platinum 5NXG Oxygen Concentrator?

The FDA 510(k) record lists Invacare Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Invacare Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 14 devices →

Related Devices (Code: CAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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