FDA 510(k)

超管（TR-1208A）；超管（TR-1504A）；超管（TR-1507A）

K 號：K230752 · 2023-09-15

申請人FUJIFILM Healthcare Americas Corporation

決定日期2023-09-15

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K230752. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K230752.

When did Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) receive FDA 510(k) clearance?

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) received FDA 510(k) clearance on 2023-09-15, under 510(k) number K230752.

Who is the listed applicant for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)?

The FDA product code for Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) is FED.

其他以 FUJIFILM Healthcare Americas Corporation 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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相關器械（代碼：FED）

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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