FDA 510(k)

計劃醫療設備 XFI

K 號：K250318 · 2025-09-26

決定日期2025-09-26

產品代碼SFV

諮詢委員會RA

決定相當於

器材摘要

Planmed XFI is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K250318. The device is classified under product code SFV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Planmed XFI?

Planmed XFI is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Planmed OY. The 510(k) number is K250318.

When did Planmed XFI receive FDA 510(k) clearance?

Planmed XFI received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250318.

Who is the listed applicant for Planmed XFI?

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

What is the FDA product code for Planmed XFI?

The FDA product code for Planmed XFI is SFV.

其他以 Planmed OY 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。

K211720Planmed Clarity 2D, Planmed Clarify S K213278Planmed Verity K192317Planmed Clarity 2D 及 Clarity S 医療設備規範文本 K180918Planmed Verity K163328Planmed 清晰

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

其他以 Planmed OY 為申請人之記錄

官方來源