FastStroke
K号: K163281 · 2017-01-26
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器械摘要
FastStroke is the device name listed in this FDA 510(k) record. The listed applicant is Gef Medical Systems Scs. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163281. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the FastStroke?
FastStroke is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Gef Medical Systems Scs. The 510(k) number is K163281.
When did FastStroke receive FDA 510(k) clearance?
FastStroke received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163281.
Who is the listed applicant for FastStroke?
The FDA 510(k) record lists Gef Medical Systems Scs as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FastStroke?
The FDA product code for FastStroke is JAK.
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相关器械（代码：JAK）
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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