FDA 510(k)

Serafin®

K 號：K251758 · 2025-09-11

決定日期2025-09-11

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

Serafin® is the device name listed in this FDA 510(k) record. The listed applicant is Tns Co., Ltd.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251758. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Serafin®?

Serafin® is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Tns Co., Ltd.. The 510(k) number is K251758.

When did Serafin® receive FDA 510(k) clearance?

Serafin® received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251758.

Who is the listed applicant for Serafin®?

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

What is the FDA product code for Serafin®?

The FDA product code for Serafin® is NXC.

其他以 Tns Co., Ltd. 為申請人之記錄

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K232074Serafin®

相關器械（代碼：NXC）

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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