FDA 510(k)

S線

K 號：K182193 · 2019-01-22

決定日期2019-01-22

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

S-Line is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K182193. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the S-Line?

S-Line is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K182193.

When did S-Line receive FDA 510(k) clearance?

S-Line received FDA 510(k) clearance on 2019-01-22, under 510(k) number K182193.

Who is the listed applicant for S-Line?

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

What is the FDA product code for S-Line?

The FDA product code for S-Line is NJM.

其他以 Biocetec Co., Ltd. 為申請人之記錄

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相關器械（代碼：NJM）

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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