FDA 510(k)

T-FIT

K 號：K231913 · 2024-02-08

決定日期2024-02-08

產品代碼OAT

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Techwin Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K231932TDS（TECHWIN 齿科系統）

相關器械（代碼：OAT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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