FDA 510(k)

TK 靜脈內注射設備套組

K 號：K191640 · 2020-08-26

申請人Anhui Tiankang Medical Technology Co., Ltd.

決定日期2020-08-26

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

TK Intravascular Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K191640. 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 TK Intravascular Administration Set?

TK Intravascular Administration Set is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191640.

When did TK Intravascular Administration Set receive FDA 510(k) clearance?

TK Intravascular Administration Set received FDA 510(k) clearance on 2020-08-26, under 510(k) number K191640.

Who is the listed applicant for TK Intravascular Administration Set?

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

What is the FDA product code for TK Intravascular Administration Set?

The FDA product code for TK Intravascular Administration Set is FPA.

其他以 Anhui Tiankang Medical Technology Co., Ltd. 為申請人之記錄

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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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