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FDA 510(k)

Rockwell Medical CitraPure 酸濃縮液

K 號：K160847 · 2016-10-20

申請人Rockwell Medical
決定日期2016-10-20
產品代碼KPO
諮詢委員會GU
決定相當於

器材摘要

Rockwell Medical CitraPure Acid Concetrate is the device name listed in this FDA 510(k) record. The listed applicant is Rockwell Medical. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K160847. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rockwell Medical CitraPure Acid Concetrate?

Rockwell Medical CitraPure Acid Concetrate is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Rockwell Medical. The 510(k) number is K160847.

When did Rockwell Medical CitraPure Acid Concetrate receive FDA 510(k) clearance?

Rockwell Medical CitraPure Acid Concetrate received FDA 510(k) clearance on 2016-10-20, under 510(k) number K160847.

Who is the listed applicant for Rockwell Medical CitraPure Acid Concetrate?

The FDA 510(k) record lists Rockwell Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rockwell Medical CitraPure Acid Concetrate?

The FDA product code for Rockwell Medical CitraPure Acid Concetrate is KPO.

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：KPO）

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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