FDA 510(k)

Arc Enterocuff

K 號：K191330 · 2020-01-31

決定日期2020-01-31

產品代碼FDA

諮詢委員會GU

決定相當於

器材摘要

Arc Enterocuff is the device name listed in this FDA 510(k) record. The listed applicant is Boddingtons Plastics, Ltd.. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K191330. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arc Enterocuff?

Arc Enterocuff is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is Boddingtons Plastics, Ltd.. The 510(k) number is K191330.

When did Arc Enterocuff receive FDA 510(k) clearance?

Arc Enterocuff received FDA 510(k) clearance on 2020-01-31, under 510(k) number K191330.

Who is the listed applicant for Arc Enterocuff?

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

What is the FDA product code for Arc Enterocuff?

The FDA product code for Arc Enterocuff is FDA.

其他以 Boddingtons Plastics, Ltd. 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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官方來源

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