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FDA 510(k)

Bluezone Model RX-450 Air Purifier

K-Number: K212824 · 2022-02-17

ApplicantBluezone Products, Inc.
Decision Date2022-02-17
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bluezone Model RX-450 Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Bluezone Products, Inc.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K212824. 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 Bluezone Model RX-450 Air Purifier?

Bluezone Model RX-450 Air Purifier is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Bluezone Products, Inc.. The 510(k) number is K212824.

When did Bluezone Model RX-450 Air Purifier receive FDA 510(k) clearance?

Bluezone Model RX-450 Air Purifier received FDA 510(k) clearance on 2022-02-17, under 510(k) number K212824.

Who is the listed applicant for Bluezone Model RX-450 Air Purifier?

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

What is the FDA product code for Bluezone Model RX-450 Air Purifier?

The FDA product code for Bluezone Model RX-450 Air Purifier is FRA.

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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