IS3
K号: K180527 · 2018-05-16
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决定日期2018-05-16
产品代码EKX
咨询委员会DE
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决定实质等同
器械摘要
IS3 is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180527. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IS3?
IS3 is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Hiossen, Inc.. The 510(k) number is K180527.
When did IS3 receive FDA 510(k) clearance?
IS3 received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180527.
Who is the listed applicant for IS3?
The FDA 510(k) record lists Hiossen, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IS3?
The FDA product code for IS3 is EKX.
列明Hiossen, Inc.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：EKX）
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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