Zener® (model ZEN-001-B1)— 510(k) K252128

Substantially Equivalent

Uvx, Inc.

FDA 510(k) clearance K252128 for Zener® (model ZEN-001-B1), Substantially Equivalent on 2025-09-15. Applicant: Uvx, Inc.. Device class: 2.

Clearance details

Applicant: Uvx, Inc.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 2025-07-07
Decision date: 2025-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.