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FDA 510(k)

Diversatek Healthcare PureFlo 灌洗系統 / 水壺管路

K 號：K222734 · 2022-11-08

申請人Diversatek Healthcare
決定日期2022-11-08
產品代碼OCX
諮詢委員會GU
決定相當於

器材摘要

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2022-11-08 under 510(k) number K222734. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Diversatek Healthcare. The 510(k) number is K222734.

When did Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing receive FDA 510(k) clearance?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing received FDA 510(k) clearance on 2022-11-08, under 510(k) number K222734.

Who is the listed applicant for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

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

What is the FDA product code for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

The FDA product code for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is OCX.

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

其他以 Diversatek Healthcare 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。

K230056MiVu™ 食管內視鏡帽K190208Diversatek Healthcare 高解析阻抗測量法探針 (HRiM)

相關器械（代碼：OCX）

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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