FDA 510(k)

水壺（MAJ-901）；水壺（MAJ-902）

K 號：K242357 · 2024-10-07

決定日期2024-10-07

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Water Container (MAJ-901); Water Container (MAJ-902) 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 2024-10-07 under 510(k) number K242357. 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 Water Container (MAJ-901); Water Container (MAJ-902)?

Water Container (MAJ-901); Water Container (MAJ-902) is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K242357.

When did Water Container (MAJ-901); Water Container (MAJ-902) receive FDA 510(k) clearance?

Water Container (MAJ-901); Water Container (MAJ-902) received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242357.

Who is the listed applicant for Water Container (MAJ-901); Water Container (MAJ-902)?

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 Water Container (MAJ-901); Water Container (MAJ-902)?

The FDA product code for Water Container (MAJ-901); Water Container (MAJ-902) is OCX.

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。

K251986輔助水管 MAJ-855Olympus Medical Systems Corporation K251997單次使用病理切片閥 (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704內視鏡式水泵Hangzhou AGS MedTech Co., Ltd.K241874吸引針 (2189)Hobbs Medical, Inc.K242134ClearCap 遠端連接器Finemedix Co., Ltd.

官方來源

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