FDA 510(k)

血液採集針（含/不含針筒）

K 號：K223323 · 2023-03-24

申請人Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

決定日期2023-03-24

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Blood Collection Needle (with/without Needle Holder) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K223323. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Blood Collection Needle (with/without Needle Holder)?

Blood Collection Needle (with/without Needle Holder) is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K223323.

When did Blood Collection Needle (with/without Needle Holder) receive FDA 510(k) clearance?

Blood Collection Needle (with/without Needle Holder) received FDA 510(k) clearance on 2023-03-24, under 510(k) number K223323.

Who is the listed applicant for Blood Collection Needle (with/without Needle Holder)?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Collection Needle (with/without Needle Holder)?

The FDA product code for Blood Collection Needle (with/without Needle Holder) is JKA.

其他以 Anhui Hongyu Wuzhou Medical Manufacturer 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。

K234024HWJECT 自動停用針筒 K230061胰島素針筒 K230043胰島素針筒 K222124無菌皮下注射針筒（含/不含針頭）、皮下注射針 K222141安全血液採集針（不含針筒）K220900安全血液採集針（含/不含針筒）

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相關器械（代碼：JKA）

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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