Therm-X
K-Number: K190854 · 2019-05-10
Device Summary
Frequently Asked Questions
What is the Therm-X?
Therm-X is a medical device that received FDA 510(k) clearance on 2019-05-10. The listed applicant is Zenith Technical Innovations. The 510(k) number is K190854.
When did Therm-X receive FDA 510(k) clearance?
Therm-X received FDA 510(k) clearance on 2019-05-10, under 510(k) number K190854.
Who is the listed applicant for Therm-X?
The FDA 510(k) record lists Zenith Technical Innovations as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Therm-X?
The FDA product code for Therm-X is IRP.
Other records listing Zenith Technical Innovations as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IRP)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.