FDA 510(k)

T-FIT

K-Number: K231913 · 2024-02-08

Decision Date2024-02-08

Product CodeOAT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

T-FIT is the device name listed in this FDA 510(k) record. The listed applicant is Techwin Co., Ltd.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K231913. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-FIT?

T-FIT is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Techwin Co., Ltd.. The 510(k) number is K231913.

When did T-FIT receive FDA 510(k) clearance?

T-FIT received FDA 510(k) clearance on 2024-02-08, under 510(k) number K231913.

Who is the listed applicant for T-FIT?

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

What is the FDA product code for T-FIT?

The FDA product code for T-FIT is OAT.

Other records listing Techwin Co., Ltd. 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.

K231932TDS (TECHWIN DENTAL SYSTEM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.