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FDA 510(k)

輔助水管 MAJ-855

K 號:K251986 · 2025-09-26

決定日期2025-09-26
產品代碼OCX
諮詢委員會GU
決定相當於

器材摘要

AUXILIARY WATER TUBE MAJ-855 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251986. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AUXILIARY WATER TUBE MAJ-855?

AUXILIARY WATER TUBE MAJ-855 is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K251986.

When did AUXILIARY WATER TUBE MAJ-855 receive FDA 510(k) clearance?

AUXILIARY WATER TUBE MAJ-855 received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251986.

Who is the listed applicant for AUXILIARY WATER TUBE MAJ-855?

FDA 510(k) 記錄中將Olympus Medical Systems Corporation列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for AUXILIARY WATER TUBE MAJ-855?

The FDA product code for AUXILIARY WATER TUBE MAJ-855 is OCX.

相關臨床試驗

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。

其他以 Olympus Medical Systems Corporation 為申請人之記錄

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相關器械(代碼:OCX)

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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