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FDA 510(k)

富士通內視鏡型號 EC-600HL 及 EC-600LS

K 號：K162622 · 2016-10-18

申請人Fujifilm Medical Systems U.S.A, Inc.
決定日期2016-10-18
產品代碼FDF
諮詢委員會GU
決定相當於

器材摘要

Fujifilm Endoscope Models EC-600HL and EC-600LS is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162622. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fujifilm Endoscope Models EC-600HL and EC-600LS?

Fujifilm Endoscope Models EC-600HL and EC-600LS is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162622.

When did Fujifilm Endoscope Models EC-600HL and EC-600LS receive FDA 510(k) clearance?

Fujifilm Endoscope Models EC-600HL and EC-600LS received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162622.

Who is the listed applicant for Fujifilm Endoscope Models EC-600HL and EC-600LS?

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

What is the FDA product code for Fujifilm Endoscope Models EC-600HL and EC-600LS?

The FDA product code for Fujifilm Endoscope Models EC-600HL and EC-600LS is FDF.

相關臨床試驗

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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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