FDA 510(k)

rTOP

K 號：K243333 · 2025-02-04

決定日期2025-02-04

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

rTOP is the device name listed in this FDA 510(k) record. The listed applicant is Roclub GmbH. It received FDA 510(k) clearance on 2025-02-04 under 510(k) number K243333. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the rTOP?

rTOP is a medical device that received FDA 510(k) clearance on 2025-02-04. The listed applicant is Roclub GmbH. The 510(k) number is K243333.

When did rTOP receive FDA 510(k) clearance?

rTOP received FDA 510(k) clearance on 2025-02-04, under 510(k) number K243333.

Who is the listed applicant for rTOP?

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

What is the FDA product code for rTOP?

The FDA product code for rTOP is LLZ.

相關器械（代碼：LLZ）

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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