Cleared Traditional

ViroZap Indoor Air Purifier, In Duct Model 1008

K241140 · Applied Photonix, LLC · General Hospital
Aug 2024
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K241140 is an FDA 510(k) clearance for the ViroZap Indoor Air Purifier, In Duct Model 1008, a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Applied Photonix, LLC (Tampa, US). The FDA issued a Cleared decision on August 1, 2024, 99 days after receiving the submission on April 24, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K241140 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2024
Decision Date August 01, 2024
Days to Decision 99 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