Cleared Traditional

Airgle Room Air Purifier

K232645 · Airgle Corporation · General Hospital
Feb 2024
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K232645 is an FDA 510(k) clearance for the Airgle Room Air Purifier, a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Airgle Corporation (Holbrook, US). The FDA issued a Cleared decision on February 16, 2024, 170 days after receiving the submission on August 30, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K232645 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2023
Decision Date February 16, 2024
Days to Decision 170 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRA — Purifier, Air, Ultraviolet, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6500