FDA 510(k)

一次性針頭輸液器

K 號：K232475 · 2024-05-10

申請人Shandong Zhushi Pharmaceutical Group Co., Ltd.

決定日期2024-05-10

產品代碼FPA

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

Disposable infusion set with needle is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K232475. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable infusion set with needle?

Disposable infusion set with needle is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Shandong Zhushi Pharmaceutical Group Co., Ltd.. The 510(k) number is K232475.

When did Disposable infusion set with needle receive FDA 510(k) clearance?

Disposable infusion set with needle received FDA 510(k) clearance on 2024-05-10, under 510(k) number K232475.

Who is the listed applicant for Disposable infusion set with needle?

The FDA 510(k) record lists Shandong Zhushi Pharmaceutical Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable infusion set with needle?

The FDA product code for Disposable infusion set with needle is FPA.