FDA 510(k)

Nio Color 2MP（MDNC-2521）；Nio Color 3MP（MDNC-3521）

K号: K230520 · 2023-03-21

决定日期2023-03-21

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-2521); Nio Color 3MP (MDNC-3521) 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 2023-03-21 under 510(k) number K230520. 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-2521); Nio Color 3MP (MDNC-3521)?

Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Barco N.V.. The 510(k) number is K230520.

When did Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) receive FDA 510(k) clearance?

Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) received FDA 510(k) clearance on 2023-03-21, under 510(k) number K230520.

Who is the listed applicant for Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)?

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-2521); Nio Color 3MP (MDNC-3521)?

The FDA product code for Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) 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。

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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。