FDA 510(k)

RiX70 DC

K 號：K182206 · 2018-09-13

決定日期2018-09-13

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

RiX70 DC is the device name listed in this FDA 510(k) record. The listed applicant is Trident S.R.L. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K182206. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RiX70 DC?

RiX70 DC is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Trident S.R.L. The 510(k) number is K182206.

When did RiX70 DC receive FDA 510(k) clearance?

RiX70 DC received FDA 510(k) clearance on 2018-09-13, under 510(k) number K182206.

Who is the listed applicant for RiX70 DC?

The FDA 510(k) record lists Trident S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RiX70 DC?

The FDA product code for RiX70 DC is EHD.

其他以 Trident S.R.L 為申請人之記錄

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相關器械（代碼：EHD）

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