FDA 510(k)

Myriad SPECTRA光源

K 號：K232567 · 2024-03-14

決定日期2024-03-14

產品代碼QFX

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Myriad SPECTRA Light Source is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232567. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Myriad SPECTRA Light Source?

Myriad SPECTRA Light Source is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Nico Corporation. The 510(k) number is K232567.

When did Myriad SPECTRA Light Source receive FDA 510(k) clearance?

Myriad SPECTRA Light Source received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232567.

Who is the listed applicant for Myriad SPECTRA Light Source?

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 Myriad SPECTRA Light Source?

The FDA product code for Myriad SPECTRA Light Source is QFX.

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。

K191599NICO 多元 NOVUS K182340NICO 多元 K172433NICO 大腦通路 K161307NICO 多元 K162075NICO 三合一手持式醫療設備

相關器械（代碼：QFX）

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。

K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K240215藍色400；藍色400 SCarl Zeiss Meditec, AG K211346藍色 400Carl Zeiss Meditec, AG

官方來源

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