Swift System
K号: K181941 · 2018-10-18
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器械摘要
Swift System is the device name listed in this FDA 510(k) record. The listed applicant is Emblation , Ltd.. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181941. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Swift System?
Swift System is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Emblation , Ltd.. The 510(k) number is K181941.
When did Swift System receive FDA 510(k) clearance?
Swift System received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181941.
Who is the listed applicant for Swift System?
The FDA 510(k) record lists Emblation , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Swift System?
The FDA product code for Swift System is NEY.
相关临床试验
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。
列明Emblation , Ltd.为申报人的其他记录
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。
相关器械（代码：NEY）
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
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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