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510(k) K252128

Zener® (model ZEN-001-B1) by Uvx, Inc. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2025
Date Received
July 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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