FDA 510(k)

內支氣管管

K 號：K152251 · 2016-06-10

申請人Henan Tuoren Medical Device Co., Ltd.

決定日期2016-06-10

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

Endobronchial Tube is the device name listed in this FDA 510(k) record. The listed applicant is Henan Tuoren Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K152251. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endobronchial Tube?

Endobronchial Tube is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Henan Tuoren Medical Device Co., Ltd.. The 510(k) number is K152251.

When did Endobronchial Tube receive FDA 510(k) clearance?

Endobronchial Tube received FDA 510(k) clearance on 2016-06-10, under 510(k) number K152251.

Who is the listed applicant for Endobronchial Tube?

The FDA 510(k) record lists Henan Tuoren Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endobronchial Tube?

The FDA product code for Endobronchial Tube is CBI.

相關器械（代碼：CBI）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：CBI）

官方來源