FDA 510(k)

TDS（TECHWIN 齿科系統）

K 號：K231932 · 2024-08-20

決定日期2024-08-20

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

TDS (TECHWIN DENTAL SYSTEM) 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 2024-08-20 under 510(k) number K231932. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TDS (TECHWIN DENTAL SYSTEM)?

TDS (TECHWIN DENTAL SYSTEM) is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Techwin Co., Ltd.. The 510(k) number is K231932.

When did TDS (TECHWIN DENTAL SYSTEM) receive FDA 510(k) clearance?

TDS (TECHWIN DENTAL SYSTEM) received FDA 510(k) clearance on 2024-08-20, under 510(k) number K231932.

Who is the listed applicant for TDS (TECHWIN DENTAL SYSTEM)?

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 TDS (TECHWIN DENTAL SYSTEM)?

The FDA product code for TDS (TECHWIN DENTAL SYSTEM) is NHA.

其他以 Techwin Co., Ltd. 為申請人之記錄

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K231913T-FIT

相關器械（代碼：NHA）

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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