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FDA 510(k)

循環器排液袋組

K 號:K173363 · 2018-01-24

決定日期2018-01-24
產品代碼KDJ
諮詢委員會GU
決定相當於

器材摘要

Cycler Drain Bag Set 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 2018-01-24 under 510(k) number K173363. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cycler Drain Bag Set?

Cycler Drain Bag Set is a medical device that received FDA 510(k) clearance on 2018-01-24. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K173363.

When did Cycler Drain Bag Set receive FDA 510(k) clearance?

Cycler Drain Bag Set received FDA 510(k) clearance on 2018-01-24, under 510(k) number K173363.

Who is the listed applicant for Cycler Drain Bag Set?

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 Cycler Drain Bag Set?

The FDA product code for Cycler Drain Bag Set is KDJ.

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其他以 Fresenius Medical Care Renal Therapies Group, LLC 為申請人之記錄

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相關器械(代碼:KDJ)

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官方來源

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