Cleared Traditional

EOS Air Cleaner

K202766 · Guangzhou Ajax Medical Equipment Co., Ltd. · General Hospital
Jun 2021
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K202766 is an FDA 510(k) clearance for the EOS Air Cleaner, a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Guangzhou Ajax Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 11, 2021, 263 days after receiving the submission on September 21, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K202766 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2020
Decision Date June 11, 2021
Days to Decision 263 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