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FDA 510(k)

CUBE Air Purifier

K-Number: K211139 · 2021-11-26

ApplicantSamsung Electronics Co., Ltd.
Decision Date2021-11-26
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUBE Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K211139. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUBE Air Purifier?

CUBE Air Purifier is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K211139.

When did CUBE Air Purifier receive FDA 510(k) clearance?

CUBE Air Purifier received FDA 510(k) clearance on 2021-11-26, under 510(k) number K211139.

Who is the listed applicant for CUBE Air Purifier?

The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUBE Air Purifier?

The FDA product code for CUBE Air Purifier is FRA.

Other records listing Samsung Electronics Co., Ltd. as applicant

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Related Devices (Code: FRA)

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.

K252128Zener® (model ZEN-001-B1)Uvx, Inc.K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLCK232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle CorporationK221540Synexis Sphere RxSynexis, LLC

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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