FDA 510(k)

FFR V2.5

K 號：K170133 · 2017-05-26

決定日期2017-05-26

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

FFR V2.5 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Volcano. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170133. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FFR V2.5?

FFR V2.5 is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Philips Volcano. The 510(k) number is K170133.

When did FFR V2.5 receive FDA 510(k) clearance?

FFR V2.5 received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170133.

Who is the listed applicant for FFR V2.5?

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

What is the FDA product code for FFR V2.5?

The FDA product code for FFR V2.5 is IYO.

其他以 Philips Volcano 為申請人之記錄

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K162418先鋒加號導管

相關器械（代碼：IYO）

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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