510(k) K241140

ViroZap Indoor Air Purifier, In Duct Model 1008 by Applied Photonix, LLC — Product Code FRA

K241140 is an FDA 510(k) premarket notification submitted by Applied Photonix, LLC for the device "ViroZap Indoor Air Purifier, In Duct Model 1008". The FDA issued a decision of Substantially Equivalent on August 1, 2024. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
April 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type