FDA 510(k)

無菌單次使用輸液套管

K 號：K163160 · 2017-04-20

申請人Jiangxi Hongda Medical Equipment Group , Ltd.

決定日期2017-04-20

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

Sterile Single-use Infusion Set is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K163160. 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 Sterile Single-use Infusion Set?

Sterile Single-use Infusion Set is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163160.

When did Sterile Single-use Infusion Set receive FDA 510(k) clearance?

Sterile Single-use Infusion Set received FDA 510(k) clearance on 2017-04-20, under 510(k) number K163160.

Who is the listed applicant for Sterile Single-use Infusion Set?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single-use Infusion Set?

The FDA product code for Sterile Single-use Infusion Set is FPA.

其他以 Jiangxi Hongda Medical Equipment Group , 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。

K211753無菌針筒，配安全針 K210578醫用尼龍檢查手套（無電力，藍色）K210821醫療用PVC檢查手套 K163162單次使用无菌皮下注射安全針 K163161無菌一次性針筒

相關器械（代碼：FPA）

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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