PUREtrace™
K号: K153262 · 2017-02-07
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决定日期2017-02-07
产品代码OSP
咨询委员会OB
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决定实质等同
器械摘要
PUREtrace™ is the device name listed in this FDA 510(k) record. The listed applicant is Nemo Healthcare BV. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K153262. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PUREtrace™?
PUREtrace™ is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Nemo Healthcare BV. The 510(k) number is K153262.
When did PUREtrace™ receive FDA 510(k) clearance?
PUREtrace™ received FDA 510(k) clearance on 2017-02-07, under 510(k) number K153262.
Who is the listed applicant for PUREtrace™?
The FDA 510(k) record lists Nemo Healthcare BV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PUREtrace™?
The FDA product code for PUREtrace™ is OSP.
相关临床试验
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相关器械（代码：OSP）
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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