FDA 510(k)

光學顯微系統 ETG-4100

K 號：K172492 · 2018-08-17

決定日期2018-08-17

產品代碼DQA

諮詢委員會履歷

決定相當於

器材摘要

Optical Topography System ETG-4100 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K172492. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optical Topography System ETG-4100?

Optical Topography System ETG-4100 is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K172492.

When did Optical Topography System ETG-4100 receive FDA 510(k) clearance?

Optical Topography System ETG-4100 received FDA 510(k) clearance on 2018-08-17, under 510(k) number K172492.

Who is the listed applicant for Optical Topography System ETG-4100?

The FDA 510(k) record lists Hitachi Healthcare Americas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optical Topography System ETG-4100?

The FDA product code for Optical Topography System ETG-4100 is DQA.

其他以 Hitachi Healthcare Americas 為申請人之記錄

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相關器械（代碼：DQA）

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