E-CUBE 8
K号: K181617 · 2018-10-11
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器械摘要
E-CUBE 8 is the device name listed in this FDA 510(k) record. The listed applicant is Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K181617. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the E-CUBE 8?
E-CUBE 8 is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K181617.
When did E-CUBE 8 receive FDA 510(k) clearance?
E-CUBE 8 received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181617.
Who is the listed applicant for E-CUBE 8?
The FDA 510(k) record lists Alpinion Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E-CUBE 8?
The FDA product code for E-CUBE 8 is IYN.
列明Alpinion Medical Systems Co., 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：IYN）
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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