FDA 510(k)

NICO Myriad NOVUS

K号: K191599 · 2019-09-13

决定日期2019-09-13

产品代码GEI

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决定实质等同

器械摘要

NICO Myriad NOVUS is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K191599. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NICO Myriad NOVUS?

NICO Myriad NOVUS is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Nico Corporation. The 510(k) number is K191599.

When did NICO Myriad NOVUS receive FDA 510(k) clearance?

NICO Myriad NOVUS received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191599.

Who is the listed applicant for NICO Myriad NOVUS?

The FDA 510(k) record lists Nico Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICO Myriad NOVUS?

The FDA product code for NICO Myriad NOVUS is GEI.

列明Nico Corporation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。

K232567Myriad SPECTRA 光源 K182340NICO Myriad K172433NICO BrainPath K161307NICO Myriad K162075NICO TRIOwand

相关器械（代码：GEI）

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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