FDA 510(k)

STERiJECT 低死腔，STERiJECT 無形針

K 號：K231734 · 2024-03-08

申請人Tsk Laboratory International Japan KK

決定日期2024-03-08

產品代碼QNS

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

STERiJECT Low Dead Space, STERiJECT The Invisible Needle is the device name listed in this FDA 510(k) record. The listed applicant is Tsk Laboratory International Japan KK. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K231734. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

STERiJECT Low Dead Space, STERiJECT The Invisible Needle is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Tsk Laboratory International Japan KK. The 510(k) number is K231734.

When did STERiJECT Low Dead Space, STERiJECT The Invisible Needle receive FDA 510(k) clearance?

STERiJECT Low Dead Space, STERiJECT The Invisible Needle received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231734.

Who is the listed applicant for STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

The FDA 510(k) record lists Tsk Laboratory International Japan KK as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERiJECT Low Dead Space, STERiJECT The Invisible Needle?

The FDA product code for STERiJECT Low Dead Space, STERiJECT The Invisible Needle is QNS.

其他以 Tsk Laboratory International Japan KK 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。

K242073STERiJECT 眼科針；STERiJECT 眼科針低死空間 (LDS)

相關器械（代碼：QNS）

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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