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FDA 510(k)

安全蝴蝶型血液採集針，蝴蝶型血液採集針，筆型血液採集針，安全筆

K 號：K213146 · 2023-10-27

申請人Jiangsu Rongye Technology Co., Ltd.
決定日期2023-10-27
產品代碼JKA
諮詢委員會CH
決定相當於

器材摘要

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rongye Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K213146. 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 butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Jiangsu Rongye Technology Co., Ltd.. The 510(k) number is K213146.

When did Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen receive FDA 510(k) clearance?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen received FDA 510(k) clearance on 2023-10-27, under 510(k) number K213146.

Who is the listed applicant for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

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

What is the FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

The FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is JKA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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