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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 a medical device manufactured by Techwin Co., Ltd.. It received FDA 510(k) clearance on 2024-02-08 under approval 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. It is manufactured by Techwin Co., Ltd.. The 510(k) number is K231913.

When was T-FIT approved by the FDA?

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

What company makes T-FIT?

T-FIT is manufactured by Techwin Co., Ltd..

What is the FDA product code for T-FIT?

The FDA product code for T-FIT is OAT.

Other Devices by Techwin Co., Ltd.

Related Devices (Code: OAT)

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.