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FDA 510(k)

Q視覺無菌單次使用成人柔軟胃鏡(G-100);Q基礎可重複使用基座單元(Q-100)

K 號:K232028 · 2023-11-17

決定日期2023-11-17
產品代碼FDS
諮詢委員會GU
決定相當於

器材摘要

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is the device name listed in this FDA 510(k) record. The listed applicant is Iq Endoscopes Limited. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K232028. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Iq Endoscopes Limited. The 510(k) number is K232028.

When did Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) receive FDA 510(k) clearance?

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) received FDA 510(k) clearance on 2023-11-17, under 510(k) number K232028.

Who is the listed applicant for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

The FDA 510(k) record lists Iq Endoscopes Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)?

The FDA product code for Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) is FDS.

相關臨床試驗

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相關器械(代碼:FDS)

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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