FDA 510(k)

Arc EndoCuff 及 Arc EndoCuff Vision

K 號：K162205 · 2016-12-09

決定日期2016-12-09

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

Arc EndoCuff and Arc EndoCuff Vision 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 2016-12-09 under 510(k) number K162205. 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 Arc EndoCuff and Arc EndoCuff Vision?

Arc EndoCuff and Arc EndoCuff Vision is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Boddingtons Plastics, Ltd.. The 510(k) number is K162205.

When did Arc EndoCuff and Arc EndoCuff Vision receive FDA 510(k) clearance?

Arc EndoCuff and Arc EndoCuff Vision received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162205.

Who is the listed applicant for Arc EndoCuff and Arc EndoCuff Vision?

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 EndoCuff and Arc EndoCuff Vision?

The FDA product code for Arc EndoCuff and Arc EndoCuff Vision is FED.

其他以 Boddingtons Plastics, Ltd. 為申請人之記錄

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官方來源

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