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FDA 510(k)

Invacare Perfecto2V Oxygen Concentrator

K-Number: K200890 · 2020-08-06

Decision Date2020-08-06
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Invacare Perfecto2V 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 2020-08-06 under 510(k) number K200890. 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 Perfecto2V Oxygen Concentrator?

Invacare Perfecto2V Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Invacare Corporation. The 510(k) number is K200890.

When did Invacare Perfecto2V Oxygen Concentrator receive FDA 510(k) clearance?

Invacare Perfecto2V Oxygen Concentrator received FDA 510(k) clearance on 2020-08-06, under 510(k) number K200890.

Who is the listed applicant for Invacare Perfecto2V 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 Perfecto2V Oxygen Concentrator?

The FDA product code for Invacare Perfecto2V 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.