FDA 510(k)

Nio Color 2MP（MDNC-2123）

K号: K171812 · 2017-07-19

决定日期2017-07-19

产品代码PGY

咨询委员会RA

决定实质等同

器械摘要

Nio Color 2MP (MDNC-2123) is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K171812. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nio Color 2MP (MDNC-2123)?

Nio Color 2MP (MDNC-2123) is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Barco N.V.. The 510(k) number is K171812.

When did Nio Color 2MP (MDNC-2123) receive FDA 510(k) clearance?

Nio Color 2MP (MDNC-2123) received FDA 510(k) clearance on 2017-07-19, under 510(k) number K171812.

Who is the listed applicant for Nio Color 2MP (MDNC-2123)?

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

What is the FDA product code for Nio Color 2MP (MDNC-2123)?

The FDA product code for Nio Color 2MP (MDNC-2123) is PGY.

列明Barco N.V.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。

K243307LCD 显示器 (MDEC-2523)K242008Coronis OneLook K233693Nio Color 8MP（MDNC-8132）K230520Nio Color 2MP（MDNC-2521）；Nio Color 3MP（MDNC-3521）K213957Demetra Dermatoscope BDEM-01 K203364MDPC-8127

查看所有 18 个设备 →

官方来源

在 FDA 数据库中查看 →

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。