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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 the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2016-09-27 under 510(k) 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. The listed applicant is Invacare Corporation. The 510(k) number is K160630.

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

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

Who is the listed applicant for Invacare Platinum Mobile 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 Platinum Mobile Oxygen Concentrator?

The FDA product code for Invacare Platinum Mobile 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.

K203210Invacare Platinum 5NXG Oxygen ConcentratorK202379Invacare AVIVA Storm RX Power ChairK200890Invacare Perfecto2V Oxygen ConcentratorK192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPK191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with ConnectivityK182946Invacare TDX SP2-HD with Captain's Seat

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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

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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