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FDA 510(k)

終端檢視器

K 號:K211326 · 2021-11-19

決定日期2021-11-19
產品代碼QNP
諮詢委員會GU
決定相當於

器材摘要

EndoScreener is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Wision Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211326. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoScreener?

EndoScreener is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Chengdu Wision Medical Device Co., Ltd.. The 510(k) number is K211326.

When did EndoScreener receive FDA 510(k) clearance?

EndoScreener received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211326.

Who is the listed applicant for EndoScreener?

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

What is the FDA product code for EndoScreener?

The FDA product code for EndoScreener is QNP.

相關臨床試驗

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相關器械(代碼:QNP)

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。

官方來源

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