Therm-X (Home); Therm-X (AT)— 510(k) K240125

Name: FDA 510(k) clearance K240125
Creator: U.S. Food and Drug Administration
Published: 2024-06-21

Substantially Equivalent

Zenith Technical Innovations

FDA 510(k) clearance K240125 for Therm-X (Home); Therm-X (AT), Substantially Equivalent on 2024-06-21. Applicant: Zenith Technical Innovations. Device class: 2.

Clearance details

Applicant: Zenith Technical Innovations
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2024-01-16
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Gurnee, IL, US

Download summary PDF View on FDA.gov ↗

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