FDA 510(k)

光導纜線

K 號：K223183 · 2023-01-13

決定日期2023-01-13

產品代碼HBI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Light-Guide Cables is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223183. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Light-Guide Cables?

Light-Guide Cables is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K223183.

When did Light-Guide Cables receive FDA 510(k) clearance?

Light-Guide Cables received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223183.

Who is the listed applicant for Light-Guide Cables?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light-Guide Cables?

The FDA product code for Light-Guide Cables is HBI.

其他以 Olympus Winter & Ibe GmbH 為申請人之記錄

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相關器械（代碼：HBI）

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。

K163185OptiLux LED照明器Isolux, LLC

官方來源

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