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FDA 510(k)

E-Cath

K 號:K152952 · 2016-07-13

決定日期2016-07-13
產品代碼BSO
諮詢委員會AN
決定Substantially Equivalent

器材摘要

E-Cath is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2016-07-13 under 510(k) number K152952. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the E-Cath?

E-Cath is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K152952.

When did E-Cath receive FDA 510(k) clearance?

E-Cath received FDA 510(k) clearance on 2016-07-13, under 510(k) number K152952.

Who is the listed applicant for E-Cath?

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

What is the FDA product code for E-Cath?

The FDA product code for E-Cath is BSO.

其他以 PAJUNK GmbH Medizintechnologie 為申請人之記錄

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相關器械(代碼:BSO)

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