Airgle Room Air Purifier— 510(k) K232645

Substantially Equivalent

Airgle Corporation

FDA 510(k) clearance K232645 for Airgle Room Air Purifier, Substantially Equivalent on 2024-02-16. Applicant: Airgle Corporation. Device class: 2.

Clearance details

Applicant: Airgle Corporation
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2023-08-30
Decision date: 2024-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holbrook, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.