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FDA 510(k)

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

K-Number: K172648 · 2018-03-23

ApplicantDevilbiss Healthcare, LLC
Decision Date2018-03-23
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Devilbiss Healthcare, LLC. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K172648. 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 Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Devilbiss Healthcare, LLC. The 510(k) number is K172648.

When did Drive DeVilbiss iGo 2 Portable Oxygen Concentrator receive FDA 510(k) clearance?

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator received FDA 510(k) clearance on 2018-03-23, under 510(k) number K172648.

Who is the listed applicant for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

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

What is the FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator?

The FDA product code for Drive DeVilbiss iGo 2 Portable Oxygen Concentrator is CAW.

Other records listing Devilbiss Healthcare, LLC 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.

K253549DeVilbiss 5 Liter Oxygen Concentrator (555)K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)K152810DeVilbiss DV6WM Wireless Modem

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

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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