FDA 510(k)

encevis

K号: K171720 · 2018-04-19

申请人Ait Austrian Institute of Technology GmbH

决定日期2018-04-19

产品代码OMB

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决定实质等同

器械摘要

encevis is the device name listed in this FDA 510(k) record. The listed applicant is Ait Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K171720. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the encevis?

encevis is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Ait Austrian Institute of Technology GmbH. The 510(k) number is K171720.

When did encevis receive FDA 510(k) clearance?

encevis received FDA 510(k) clearance on 2018-04-19, under 510(k) number K171720.

Who is the listed applicant for encevis?

The FDA 510(k) record lists Ait Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for encevis?

The FDA product code for encevis is OMB.

列明Ait Austrian Institute of Technology GmbH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。

K240993encevis（2.1）

官方来源

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