FDA 510(k)

處理器 VP-7000，光源 BL-7000

K 號：K163675 · 2017-04-25

決定日期2017-04-25

產品代碼FET

諮詢委員會GU

決定相當於

器材摘要

Processor VP-7000, Light Source BL-7000 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K163675. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Processor VP-7000, Light Source BL-7000?

Processor VP-7000, Light Source BL-7000 is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K163675.

When did Processor VP-7000, Light Source BL-7000 receive FDA 510(k) clearance?

Processor VP-7000, Light Source BL-7000 received FDA 510(k) clearance on 2017-04-25, under 510(k) number K163675.

Who is the listed applicant for Processor VP-7000, Light Source BL-7000?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Processor VP-7000, Light Source BL-7000?

The FDA product code for Processor VP-7000, Light Source BL-7000 is FET.

其他以 Fujifilm Medical System U.S.A., Inc. 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。

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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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