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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 the device name listed in this FDA 510(k) record. The listed applicant is Tentech, Inc.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) 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. The listed applicant is Tentech, Inc.. The 510(k) number is K232992.

When did 10THERMA receive FDA 510(k) clearance?

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

Who is the listed applicant for 10THERMA?

The FDA 510(k) record lists Tentech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 10THERMA?

The FDA product code for 10THERMA is GEI.

Other records listing Tentech, Inc. 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.

K22079410PL

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Official Source

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