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FDA 510(k)

EndoPilot2

K 號:K202906 · 2021-04-13

決定日期2021-04-13
產品代碼ELC
諮詢委員會DE
決定相當於

器材摘要

EndoPilot2 is the device name listed in this FDA 510(k) record. The listed applicant is Schlumbohm GmbH & Co. KG. It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K202906. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoPilot2?

EndoPilot2 is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Schlumbohm GmbH & Co. KG. The 510(k) number is K202906.

When did EndoPilot2 receive FDA 510(k) clearance?

EndoPilot2 received FDA 510(k) clearance on 2021-04-13, under 510(k) number K202906.

Who is the listed applicant for EndoPilot2?

The FDA 510(k) record lists Schlumbohm GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoPilot2?

The FDA product code for EndoPilot2 is ELC.

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相關器械(代碼:ELC)

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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