FDA 510(k)

泰瑞慕注射過濾針 (NF-3013RBKE05M)

K 號：K230951 · 2023-10-18

決定日期2023-10-18

產品代碼QYM

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

Terumo Injection Filter Needle (NF-3013RBKE05M) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2023-10-18 under 510(k) number K230951. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Terumo Injection Filter Needle (NF-3013RBKE05M)?

Terumo Injection Filter Needle (NF-3013RBKE05M) is a medical device that received FDA 510(k) clearance on 2023-10-18. The listed applicant is Terumo Europe N.V.. The 510(k) number is K230951.

When did Terumo Injection Filter Needle (NF-3013RBKE05M) receive FDA 510(k) clearance?

Terumo Injection Filter Needle (NF-3013RBKE05M) received FDA 510(k) clearance on 2023-10-18, under 510(k) number K230951.

Who is the listed applicant for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M) is QYM.

其他以 Terumo Europe N.V. 為申請人之記錄

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K251447K-Pack Embrace 活動安全針 (KNAS-2516RB, KNAS-2525RB)K24330927G x 1/2 TW K-Pack Surshield 鋒針 (KN-S2713RBT)K243581K-Pack 增強針 (KH-2713RBBTC 和 KH-2913RBBTC)K212095SurGuard3 安全皮下針 K192057K-Pack II 鋼針 - 27G x 1/2” 非常薄壁，K-Pack II 鋼針 - 27G x 1/2” 超薄壁，K-Pack II 鋼針 - 30G x 1/2” 非常薄壁，K-Pack II 鋼針 - 30G x 1/2” 超薄壁 K161606針筒固定針 - 限與 GONAL-F 多劑量 600 I/U mL FSH 一起使用

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相關器械（代碼：QYM）

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)Tsk Laboratory International Japan KK

官方來源

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