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FDA 510(k)

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

K 號:K230520 · 2023-03-21

申請人Barco N.V.
決定日期2023-03-21
產品代碼PGY
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

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其他以 Barco N.V. 為申請人之記錄

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相關器械(代碼:PGY)

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