EMS-200
K号: K153285 · 2016-08-12
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决定日期2016-08-12
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
EMS-200 is the device name listed in this FDA 510(k) record. The listed applicant is Meta Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K153285. 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 EMS-200?
EMS-200 is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Meta Systems Co., Ltd.. The 510(k) number is K153285.
When did EMS-200 receive FDA 510(k) clearance?
EMS-200 received FDA 510(k) clearance on 2016-08-12, under 510(k) number K153285.
Who is the listed applicant for EMS-200?
The FDA 510(k) record lists Meta Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EMS-200?
The FDA product code for EMS-200 is EKX.
列明Meta 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: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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