FDA 510(k)

路氏分離 MAJ-2092

K 號：K241842 · 2025-03-19

決定日期2025-03-19

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Luer-Split MAJ-2092 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 2025-03-19 under 510(k) number K241842. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Luer-Split MAJ-2092?

Luer-Split MAJ-2092 is a medical device that received FDA 510(k) clearance on 2025-03-19. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K241842.

When did Luer-Split MAJ-2092 receive FDA 510(k) clearance?

Luer-Split MAJ-2092 received FDA 510(k) clearance on 2025-03-19, under 510(k) number K241842.

Who is the listed applicant for Luer-Split MAJ-2092?

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 Luer-Split MAJ-2092?

The FDA product code for Luer-Split MAJ-2092 is ODC.

其他以 Olympus Medical Systems Corporation 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。

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相關器械（代碼：ODC）

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。

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官方來源

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