FDA 510(k)

X1-FFR

K 號：K251355 · 2025-10-17

決定日期2025-10-17

產品代碼QHA

諮詢委員會RA

決定相當於

器材摘要

X1-FFR is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251355. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X1-FFR?

X1-FFR is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Spectrawave, Inc.. The 510(k) number is K251355.

When did X1-FFR receive FDA 510(k) clearance?

X1-FFR received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251355.

Who is the listed applicant for X1-FFR?

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

What is the FDA product code for X1-FFR?

The FDA product code for X1-FFR is QHA.

其他以 Spectrawave, Inc. 為申請人之記錄

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相關器械（代碼：QHA）

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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