FDA 510(k)

單次使用過濾針

K 號：K233277 · 2024-05-10

申請人Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

決定日期2024-05-10

產品代碼FPB

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

Filter Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K233277. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Filter Needle for Single Use?

Filter Needle for Single Use is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. The 510(k) number is K233277.

When did Filter Needle for Single Use receive FDA 510(k) clearance?

Filter Needle for Single Use received FDA 510(k) clearance on 2024-05-10, under 510(k) number K233277.

Who is the listed applicant for Filter Needle for Single Use?

FDA 510(k) 記錄將杭州錢塘龍躍生物技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Filter Needle for Single Use?

The FDA product code for Filter Needle for Single Use is FPB.

其他以 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. 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。

K260933安全性無菌皮下針筒（NR-S1816R、NR-S1916R、NR-S1925R、NR-S1938R、NR-S2016R、NR-S2025R、NR-S2038R、NR-S2051R、NR-S2116R、NR-S2125R、NR-S2138R、NR-S2151R、NR-S2216R、NR-S2225R、NR-S2238R、NR-S2251R、NR-S2316R、NR-S2325R、NR-S2338R、NR-S2351R、NR-S2516R、NR-S2525R、NR-S2538R、NR-S2551R、NR-S2516T、NR-S2525T、NR-S2538T、NR-S2551T）K260301藥劑適配器 K233287風針針筒適配器 K233284針筒適配器附濾網 K222718藥劑適配器

相關器械（代碼：FPB）

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。

K261403Lipipor NLF1A 渗透過濾器，Lipipor NLF2A 及 NLF2NTA 渗透過濾器，Lipipor TNA2A 渗透過濾器Global Life Sciences Solutions USA, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。