Airgle Room Air Purifier
K-Number: K232645 · 2024-02-16
ApplicantAirgle Corporation
Decision Date2024-02-16
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Airgle Room Air Purifier is a medical device manufactured by Airgle Corporation. It received FDA 510(k) clearance on 2024-02-16 under approval 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. It is manufactured by Airgle Corporation. The 510(k) number is K232645.
When was Airgle Room Air Purifier approved by the FDA?
Airgle Room Air Purifier received FDA 510(k) clearance on 2024-02-16, under approval number K232645.
What company makes Airgle Room Air Purifier?
Airgle Room Air Purifier is manufactured by Airgle Corporation.
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)
K161468Transformair Indoor Air PurifierTransformair, LLC
K201220Aerus Medical Guardian,model F170AAerus Medical, LLC
K200500Molekule Air Pro RXMolekule, Inc.
K211139CUBE Air PurifierSamsung Electronics Co., Ltd.
K211194Molekule Air ProMolekule, Inc.
K202766EOS Air CleanerGuangzhou Ajax 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.