Cleared Traditional

RGS; RGS Mini

K222702 · Genesis Air, Inc. · General Hospital
Jun 2023
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K222702 is an FDA 510(k) clearance for the RGS; RGS Mini, a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Genesis Air, Inc. (Lubbock, US). The FDA issued a Cleared decision on June 2, 2023, 268 days after receiving the submission on September 7, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K222702 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2022
Decision Date June 02, 2023
Days to Decision 268 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