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FDA 510(k)

Inogen Rove 6

K-Number: K230052 · 2023-06-30

ApplicantInogen, Inc.
Decision Date2023-06-30
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Inogen Rove 6 is the device name listed in this FDA 510(k) record. The listed applicant is Inogen, Inc.. It received FDA 510(k) clearance on 2023-06-30 under 510(k) 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. The listed applicant is Inogen, Inc.. The 510(k) number is K230052.

When did Inogen Rove 6 receive FDA 510(k) clearance?

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

Who is the listed applicant for Inogen Rove 6?

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

What is the FDA product code for Inogen Rove 6?

The FDA product code for Inogen Rove 6 is CAW.

Other records listing Inogen, Inc. 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.

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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.

K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLCK251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.

Official Source

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