FDA 510(k)

NICO 多元 NOVUS

K 號：K191599 · 2019-09-13

決定日期2019-09-13

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Nico Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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