FDA 510(k)

Inogen Rove 6

K-Number: K230052 · 2023-06-30

Decision Date2023-06-30

Product CodeCAW

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Inogen Rove 6 is a medical device manufactured by Inogen, Inc.. It received FDA 510(k) clearance on 2023-06-30 under approval number K230052. 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 Inogen Rove 6?

Inogen Rove 6 is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Inogen, Inc.. The 510(k) number is K230052.

When was Inogen Rove 6 approved by the FDA?

Inogen Rove 6 received FDA 510(k) clearance on 2023-06-30, under approval number K230052.

What company makes Inogen Rove 6?

Inogen Rove 6 is manufactured by Inogen, Inc..

What is the FDA product code for Inogen Rove 6?

The FDA product code for Inogen Rove 6 is CAW.

Other Devices by Inogen, Inc.

K241091SIMEOX 200 Airway Clearance Device

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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.