FDA 510(k)

Airgle Room Air Purifier

K-Number: K232645 · 2024-02-16

Decision Date2024-02-16

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Airgle Room Air Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Airgle Corporation. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K232645. 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 Airgle Room Air Purifier?

Airgle Room Air Purifier is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Airgle Corporation. The 510(k) number is K232645.

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

Airgle Room Air Purifier received FDA 510(k) clearance on 2024-02-16, under 510(k) number K232645.

Who is the listed applicant for Airgle Room Air Purifier?

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

What is the FDA product code for Airgle Room Air Purifier?

The FDA product code for Airgle Room 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, LLC K232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K221540Synexis Sphere RxSynexis, LLC K222702RGS; RGS MiniGenesis Air, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.