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FDA 510(k)

EMS-200

K号: K153285 · 2016-08-12

决定日期2016-08-12
产品代码EKX
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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。

官方来源

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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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