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FDA 510(k)

Invacare Platinum Mobile Oxygen Concentrator

K-Number: K160630 · 2016-09-27

ApplicantInvacare Corporation
Decision Date2016-09-27
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Invacare Platinum Mobile Oxygen Concentrator is a medical device manufactured by Invacare Corporation. It received FDA 510(k) clearance on 2016-09-27 under approval number K160630. 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 Mobile Oxygen Concentrator?

Invacare Platinum Mobile Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Invacare Corporation. The 510(k) number is K160630.

When was Invacare Platinum Mobile Oxygen Concentrator approved by the FDA?

Invacare Platinum Mobile Oxygen Concentrator received FDA 510(k) clearance on 2016-09-27, under approval number K160630.

What company makes Invacare Platinum Mobile Oxygen Concentrator?

Invacare Platinum Mobile Oxygen Concentrator is manufactured by Invacare Corporation.

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

The FDA product code for Invacare Platinum Mobile 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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