FDA 510(k)

pureFLOW 402 (F00012067)；pureFLOW 406 (F00012068)；pureFLOW 401 (F00012069)；pureFLOW 400 (F00012070)

K 號：K233950 · 2024-05-10

申請人Fresenius Medical Care Renal Therapies Group, LLC

決定日期2024-05-10

產品代碼KPO

諮詢委員會GU

決定相當於

器材摘要

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K233950. 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 pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)?

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K233950.

When did pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) receive FDA 510(k) clearance?

pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) received FDA 510(k) clearance on 2024-05-10, under 510(k) number K233950.

Who is the listed applicant for pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)?

FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)?

The FDA product code for pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) is KPO.

其他以 Fresenius Medical Care Renal Therapies Group, LLC 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。

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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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官方來源

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