FDA 510(k)

EZFluence

K号: K171352 · 2017-12-01

决定日期2017-12-01

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

EZFluence is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K171352. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EZFluence?

EZFluence is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Radformation, Inc.. The 510(k) number is K171352.

When did EZFluence receive FDA 510(k) clearance?

EZFluence received FDA 510(k) clearance on 2017-12-01, under 510(k) number K171352.

Who is the listed applicant for EZFluence?

FDA 510(k)记录中列出Radformation, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for EZFluence?

The FDA product code for EZFluence is IYE.

列明Radformation, 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。

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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。