FDA 510(k)

荧光模式

K 號：K171007 · 2018-05-03

決定日期2018-05-03

產品代碼NBL

諮詢委員會DE

決定相當於

器材摘要

Fluorescence Mode is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K171007. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fluorescence Mode?

Fluorescence Mode is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Carl Zeiss Suzhou Co., Ltd.. The 510(k) number is K171007.

When did Fluorescence Mode receive FDA 510(k) clearance?

Fluorescence Mode received FDA 510(k) clearance on 2018-05-03, under 510(k) number K171007.

Who is the listed applicant for Fluorescence Mode?

The FDA 510(k) record lists Carl Zeiss Suzhou Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluorescence Mode?

The FDA product code for Fluorescence Mode is NBL.

其他以 Carl Zeiss Suzhou Co., Ltd. 為申請人之記錄

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K163195PRIMUS

相關器械（代碼：NBL）

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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