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FDA 510(k)

結束 200 絶締內視鏡管路組

K 號:K202922 · 2021-07-08

決定日期2021-07-08
產品代碼FCX
諮詢委員會GU
決定相當於

器材摘要

END 200 Endoscopic Tubeset is the device name listed in this FDA 510(k) record. The listed applicant is Palliare , Ltd.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K202922. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the END 200 Endoscopic Tubeset?

END 200 Endoscopic Tubeset is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Palliare , Ltd.. The 510(k) number is K202922.

When did END 200 Endoscopic Tubeset receive FDA 510(k) clearance?

END 200 Endoscopic Tubeset received FDA 510(k) clearance on 2021-07-08, under 510(k) number K202922.

Who is the listed applicant for END 200 Endoscopic Tubeset?

The FDA 510(k) record lists Palliare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for END 200 Endoscopic Tubeset?

The FDA product code for END 200 Endoscopic Tubeset is FCX.

相關臨床試驗

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其他以 Palliare , Ltd. 為申請人之記錄

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。

相關器械(代碼:FCX)

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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