FDA 510(k)

RootMend MRR

K 號：K243988 · 2025-03-20

決定日期2025-03-20

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

RootMend MRR is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K243988. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RootMend MRR?

RootMend MRR is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K243988.

When did RootMend MRR receive FDA 510(k) clearance?

RootMend MRR received FDA 510(k) clearance on 2025-03-20, under 510(k) number K243988.

Who is the listed applicant for RootMend MRR?

The FDA 510(k) record lists Riverpoint Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RootMend MRR?

The FDA product code for RootMend MRR is MBI.

其他以 Riverpoint Medical, LLC 為申請人之記錄

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相關器械（代碼：MBI）

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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