FDA 510(k)

安全血液採集針（含/不含針筒）

K 號：K220900 · 2022-08-10

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

決定日期2022-08-10

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Safety Blood Collection Needles 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 2022-08-10 under 510(k) number K220900. 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 Safety Blood Collection Needles with/without Needle Holder?

Safety Blood Collection Needles with/without Needle Holder is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K220900.

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

Safety Blood Collection Needles with/without Needle Holder received FDA 510(k) clearance on 2022-08-10, under 510(k) number K220900.

Who is the listed applicant for Safety Blood Collection Needles 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 Safety Blood Collection Needles with/without Needle Holder?

The FDA product code for Safety Blood Collection Needles with/without Needle Holder is JKA.

其他以 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. 為申請人之記錄

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K234024HWJECT 自動停用針筒 K230061胰島素針筒 K230043胰島素針筒 K223323血液採集針（含/不含針筒）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）

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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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