Oxyless 血管导管套装
K号: K150304 · 2016-02-24
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决定日期2016-02-24
产品代码FJK
咨询委员会GU
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：FJK）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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