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FDA 510(k)

10THERMA

K-Number: K232992 · 2023-12-20

ApplicantTentech, Inc.
Decision Date2023-12-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

10THERMA is a medical device manufactured by Tentech, Inc.. It received FDA 510(k) clearance on 2023-12-20 under approval number K232992. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10THERMA?

10THERMA is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Tentech, Inc.. The 510(k) number is K232992.

When was 10THERMA approved by the FDA?

10THERMA received FDA 510(k) clearance on 2023-12-20, under approval number K232992.

What company makes 10THERMA?

10THERMA is manufactured by Tentech, Inc..

What is the FDA product code for 10THERMA?

The FDA product code for 10THERMA is GEI.

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Official Source

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