Therm-X
K-Number: K231912 · 2023-07-27
ApplicantZenith Technical Innovations
Decision Date2023-07-27
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Therm-X is a medical device manufactured by Zenith Technical Innovations. It received FDA 510(k) clearance on 2023-07-27 under approval number K231912. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Therm-X?
Therm-X is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Zenith Technical Innovations. The 510(k) number is K231912.
When was Therm-X approved by the FDA?
Therm-X received FDA 510(k) clearance on 2023-07-27, under approval number K231912.
What company makes Therm-X?
Therm-X is manufactured by Zenith Technical Innovations.
What is the FDA product code for Therm-X?
The FDA product code for Therm-X is IRP.
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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.