Therm-X— 510(k) K193550

Substantially Equivalent

Zenith Technical Innovations

FDA 510(k) clearance K193550 for Therm-X, Substantially Equivalent on 2020-02-28. Applicant: Zenith Technical Innovations.

Clearance details

Applicant: Zenith Technical Innovations
Product code: Code IRP
Advisory panel: Physical Medicine
Date received: 2019-12-20
Decision date: 2020-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurnee, IL, US

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