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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 a medical device manufactured by Bluezone Products, Inc.. It received FDA 510(k) clearance on 2022-02-17 under approval 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. It is manufactured by Bluezone Products, Inc.. The 510(k) number is K212824.

When was Bluezone Model RX-450 Air Purifier approved by the FDA?

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

What company makes Bluezone Model RX-450 Air Purifier?

Bluezone Model RX-450 Air Purifier is manufactured by Bluezone Products, Inc..

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.

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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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