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FDA 510(k)

氧氣不足血液管路組

K 號:K150304 · 2016-02-24

申請人Oxyless, Ltd.
決定日期2016-02-24
產品代碼FJK
諮詢委員會GU
決定相當於

器材摘要

Oxyless Blood Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Oxyless, Ltd.. It received FDA 510(k) clearance on 2016-02-24 under 510(k) number K150304. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oxyless Blood Tubing Set?

Oxyless Blood Tubing Set is a medical device that received FDA 510(k) clearance on 2016-02-24. The listed applicant is Oxyless, Ltd.. The 510(k) number is K150304.

When did Oxyless Blood Tubing Set receive FDA 510(k) clearance?

Oxyless Blood Tubing Set received FDA 510(k) clearance on 2016-02-24, under 510(k) number K150304.

Who is the listed applicant for Oxyless Blood Tubing Set?

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

What is the FDA product code for Oxyless Blood Tubing Set?

The FDA product code for Oxyless Blood Tubing Set is FJK.

相關臨床試驗

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相關器械(代碼:FJK)

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。

官方來源

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