FDA 510(k)

KARL STORZ OR1™ SCB 控制 (WU300)

K 號：K232406 · 2023-10-03

決定日期2023-10-03

產品代碼ODA

諮詢委員會GU

決定相當於

器材摘要

KARL STORZ OR1™ SCB CONTROL (WU300) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232406. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KARL STORZ OR1™ SCB CONTROL (WU300)?

KARL STORZ OR1™ SCB CONTROL (WU300) is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232406.

When did KARL STORZ OR1™ SCB CONTROL (WU300) receive FDA 510(k) clearance?

KARL STORZ OR1™ SCB CONTROL (WU300) received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232406.

Who is the listed applicant for KARL STORZ OR1™ SCB CONTROL (WU300)?

FDA 510(k) 記錄將 Karl Storz SE & CO. KG 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300)?

The FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300) is ODA.

其他以 Karl Storz SE & CO. KG 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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