Therm-X— 510(k) K190854

Substantially Equivalent

Zenith Technical Innovations

FDA 510(k) clearance K190854 for Therm-X, Substantially Equivalent on 2019-05-10. Applicant: Zenith Technical Innovations.

Clearance details

Applicant: Zenith Technical Innovations
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2019-04-02
Decision date: 2019-05-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Gurnee, IL, US

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