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FDA 510(k)

X-PLO2R

K-Number: K203086 · 2021-03-02

ApplicantBelluscura, LLC
Decision Date2021-03-02
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

X-PLO2R is the device name listed in this FDA 510(k) record. The listed applicant is Belluscura, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K203086. 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 X-PLO2R?

X-PLO2R is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Belluscura, LLC. The 510(k) number is K203086.

When did X-PLO2R receive FDA 510(k) clearance?

X-PLO2R received FDA 510(k) clearance on 2021-03-02, under 510(k) number K203086.

Who is the listed applicant for X-PLO2R?

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

What is the FDA product code for X-PLO2R?

The FDA product code for X-PLO2R is CAW.

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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