FDA 510(k)

Lucid M1 经颅多普勒超声系统（Lucid M1 系统）带 2MHz 探头

K号: K160442 · 2016-10-21

决定日期2016-10-21

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Neural Analytics, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160442. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Neural Analytics, Inc.. The 510(k) number is K160442.

When did Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers receive FDA 510(k) clearance?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160442.

Who is the listed applicant for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

The FDA 510(k) record lists Neural Analytics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

The FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is IYN.

列明Neural Analytics, 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。

K180455神经机器人

相关器械（代码：IYN）

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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